21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.101 Information...

21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.104 Action on a.... (d) If FDA and a manufacturer or supplier agree that the notifier may submit a food additive petition... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Action on a premarket notification for a food...

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

PubMed

1998-11-03

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification § 190.6 Requirement for premarket... dietary supplement that contains a new dietary ingredient that has not been present in the food supply as... manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office of...

78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

... (Formerly 2007D-0252)] Pulse Oximeters--Premarket Notification Submissions [510(k)s]; Guidance for Industry... entitled ``Pulse Oximeters--Premarket Notification Submissions [510(k)s].'' This guidance document pertains to non-invasive pulse oximeters intended for prescription use to measure arterial blood oxygen...

75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

... of the availability of safety and effectiveness summaries of approved PMAs through the Internet and... New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301-796- 6570. SUPPLEMENTARY... and denials in the Federal Register. Instead, the agency now posts this information on the Internet on...

75 FR 54154 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

... effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management... and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650... Federal Register. Instead, the agency now posts this information on the Internet on FDA's home page at...

75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... Federal Register. Instead, the Agency now posts this information on the Internet on FDA's home page at...

78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices in order to maintain information confidentiality, integrity, and availability. This draft guidance is not final nor is it in effect at this time.

21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170...

21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170...

EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES.

PubMed

Levin, Leslie

2015-01-01

With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.

21 CFR 807.90 - Format of a premarket notification submission.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and Drug... Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Format of a premarket notification submission. 807...

21 CFR 807.90 - Format of a premarket notification submission.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville... to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Format of a premarket notification submission. 807...

Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

PubMed

Yang, Brian W; Iorio, Matthew L; Day, Charles S

2017-03-15

The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

21 CFR 876.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 876.3 Section 876.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES General Provisions § 876.3 Effective...

21 CFR 862.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions...

21 CFR 866.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions § 866.3...

21 CFR 866.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions § 866.3...

21 CFR 866.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions § 866.3...

21 CFR 866.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions § 866.3...

21 CFR 866.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 866.3 Section 866.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES General Provisions § 866.3...

21 CFR 862.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions...

21 CFR 862.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions...

21 CFR 862.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions...

21 CFR 862.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 862.3 Section 862.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions...

PISCO: The PMAS/PPak Integral-field Supernova Hosts Compilation

NASA Astrophysics Data System (ADS)

Galbany, L.; Anderson, J. P.; Sánchez, S. F.; Kuncarayakti, H.; Pedraz, S.; González-Gaitán, S.; Stanishev, V.; Domínguez, I.; Moreno-Raya, M. E.; Wood-Vasey, W. M.; Mourão, A. M.; Ponder, K. A.; Badenes, C.; Mollá, M.; López-Sánchez, A. R.; Rosales-Ortega, F. F.; Vílchez, J. M.; García-Benito, R.; Marino, R. A.

2018-03-01

We present the PMAS/PPak Integral-field Supernova hosts COmpilation (PISCO), which comprises integral field spectroscopy (IFS) of 232 supernova (SN) host galaxies that hosted 272 SNe, observed over several semesters with the 3.5 m telescope at the Calar Alto Observatory (CAHA). PISCO is the largest collection of SN host galaxies observed with wide-field IFS, totaling 466,347 individual spectra covering a typical spatial resolution of ∼380 pc. Focused studies regarding specific SN Ia-related topics will be published elsewhere; this paper aims to present the properties of the SN environments, using stellar population (SP) synthesis, and the gas-phase interstellar medium, providing additional results separating stripped-envelope SNe into their subtypes. With 11,270 H II regions detected in all galaxies, we present for the first time a statistical analysis of H II regions, which puts H II regions that have hosted SNe in context with all other star-forming clumps within their galaxies. SNe Ic are associated with environments that are more metal-rich and have higher EW(Hα) and higher star formation rate within their host galaxies than the mean of all H II regions detected within each host. This in contrast to SNe IIb, which occur in environments that are very different compared to other core-collapse SNe types. We find two clear components of young and old SPs at SNe IIn locations. We find that SNe II fast decliners tend to explode at locations where the ΣSFR is more intense. Finally, we outline how a future dedicated IFS survey of galaxies in parallel to an untargeted SN search would overcome the biases in current environmental studies.

21 CFR 807.87 - Information required in a premarket notification submission.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

21 CFR 807.87 - Information required in a premarket notification submission.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

21 CFR 807.87 - Information required in a premarket notification submission.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

21 CFR 807.87 - Information required in a premarket notification submission.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... standards. (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended...

21 CFR 872.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 872.3 Section 872.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.3 Effective dates of...

21 CFR 872.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 872.3 Section 872.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.3 Effective dates of...

21 CFR 888.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 888.3 Section 888.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.3 Effective dates of...

21 CFR 888.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 888.3 Section 888.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.3 Effective dates of...

21 CFR 888.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 888.3 Section 888.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.3 Effective dates of...

21 CFR 888.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 888.3 Section 888.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.3 Effective dates of...

21 CFR 888.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 888.3 Section 888.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.3 Effective dates of...

21 CFR 864.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

21 CFR 864.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

21 CFR 864.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

21 CFR 864.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

21 CFR 864.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

21 CFR 878.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions § 878.3...

21 CFR 878.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions § 878.3...

21 CFR 878.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions § 878.3...

21 CFR 878.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions § 878.3...

21 CFR 878.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Effective dates of requirement for premarket approval. 878.3 Section 878.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES General Provisions § 878.3...

21 CFR 892.3 - Effective dates of requirement for premarket approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 892.3 Section 892.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.3 Effective dates of...

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

PubMed

2003-04-22

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

PubMed

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

76 FR 53851 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2011-N-0505] Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent... preamendments device: Cardiovascular permanent pacemaker electrode. The document was published with an incorrect...

A pre-marketing ALT signal predicts post-marketing liver safety.

PubMed

Moylan, Cynthia A; Suzuki, Ayako; Papay, Julie I; Yuen, Nancy A; Ames, Michael; Hunt, Christine M

2012-08-01

Drug induced liver injury during drug development is evidenced by a higher incidence of serum alanine aminotransferase (ALT) elevations in treated versus placebo populations and termed an "ALT signal". We sought to quantify whether an ALT signal in pre-marketing clinical trials predicted post-marketing hepatotoxicity. Incidence of ALT elevations (ALT ≥ 3 times upper limits normal [× ULN]) for drug and placebo of new chemical entities and approved drugs associated with hepatotoxicity was calculated using the Food and Drug Administration (FDA) website. Post-marketing liver safety events were identified using the FDA Adverse Event Reporting System (AERS). The association of FDA AERS signal score (EB05 ≥ 2) and excess risk of pre-marketing ALT elevation (difference in incidence of ALT ≥ 3× ULN in treated versus placebo) was examined. An ALT signal of ≥ 1.2% was significantly associated with a post-marketing liver safety signal (p ≤ 0.013) and a 71.4% positive predictive value. An absent ALT signal was associated with a high likelihood of post-marketing liver safety; negative predictive value of 89.7%. Daily drug dose information improved the prediction of post-marketing liver safety. A cut-off of 1.2% increase in ALT ≥ 3× ULN in treated versus placebo groups provides an easily calculated method for predicting post-marketing liver safety. Published by Elsevier Inc.

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

PubMed

Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

2015-08-11

The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer

76 FR 47085 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

.... FDA-2011-N-0526] Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer... programmers. The agency is also summarizing its proposed findings regarding the degree of risk of illness or.... Background--Regulatory Authorities The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the...

Electrical stimulation promotes nerve cell differentiation on polypyrrole/poly (2-methoxy-5 aniline sulfonic acid) composites.

PubMed

Liu, Xiao; Gilmore, Kerry J; Moulton, Simon E; Wallace, Gordon G

2009-12-01

The purpose of this work was to investigate for the first time the potential biomedical applications of novel polypyrrole (PPy) composites incorporating a large polyelectrolyte dopant, poly (2-methoxy-5 aniline sulfonic acid) (PMAS). The physical and electrochemical properties were characterized. The PPy/PMAS composites were found to be smooth and hydrophilic and have low electrical impedance. We demonstrate that PPy/PMAS supports nerve cell (PC12) differentiation, and that clinically relevant 250 Hz biphasic current pulses delivered via PPy/PMAS films significantly promote nerve cell differentiation in the presence of nerve growth factor (NGF). The capacity of PPy/PMAS composites to support and enhance nerve cell differentiation via electrical stimulation renders them valuable for medical implants for neurological applications.

78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket... issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of...

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

PubMed

Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

2017-01-01

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES...

21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES...

21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES...

21 CFR 170.101 - Information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Information in a premarket notification for a food contact substance (FCN). 170.101 Section 170.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES...

75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Action on a premarket notification for a food...

21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Action on a premarket notification for a food...

21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Action on a premarket notification for a food...

21 CFR 170.104 - Action on a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2013 CFR

2013-04-01

... OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES... agree that the notifier may submit a food additive petition proposing the approval of the food contact... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Action on a premarket notification for a food...

76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-20

... enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology... profiles and for which it believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would...

Predictive and External Validity of a Pre-Market Study to Determine the Most Effective Pictorial Health Warning Label Content for Cigarette Packages

PubMed Central

Thrasher, James F.; Reid, Jessica L.; Hammond, David

2016-01-01

Abstract Introduction: Studies examining cigarette package pictorial health warning label (HWL) content have primarily used designs that do not allow determination of effectiveness after repeated, naturalistic exposure. This research aimed to determine the predictive and external validity of a pre-market evaluation study of pictorial HWLs. Methods: Data were analyzed from: (1) a pre-market convenience sample of 544 adult smokers who participated in field experiments in Mexico City before pictorial HWL implementation (September 2010); and (2) a post-market population-based representative sample of 1765 adult smokers in the Mexican administration of the International Tobacco Control Policy Evaluation Survey after pictorial HWL implementation. Participants in both samples rated six HWLs that appeared on cigarette packs, and also ranked HWLs with four different themes. Mixed effects models were estimated for each sample to assess ratings of relative effectiveness for the six HWLs, and to assess which HWL themes were ranked as the most effective. Results: Pre- and post-market data showed similar relative ratings across the six HWLs, with the least and most effective HWLs consistently differentiated from other HWLs. Models predicting rankings of HWL themes in post-market sample indicated: (1) pictorial HWLs were ranked as more effective than text-only HWLs; (2) HWLs with both graphic and “lived experience” content outperformed symbolic content; and, (3) testimonial content significantly outperformed didactic content. Pre-market data showed a similar pattern of results, but with fewer statistically significant findings. Conclusions: The study suggests well-designed pre-market studies can have predictive and external validity, helping regulators select HWL content. PMID:26377516

Wavelength- or Polarization-Selective Thermal Infrared Detectors for Multi-Color or Polarimetric Imaging Using Plasmonics and Metamaterials.

PubMed

Ogawa, Shinpei; Kimata, Masafumi

2017-05-04

Wavelength- or polarization-selective thermal infrared (IR) detectors are promising for various novel applications such as fire detection, gas analysis, multi-color imaging, multi-channel detectors, recognition of artificial objects in a natural environment, and facial recognition. However, these functions require additional filters or polarizers, which leads to high cost and technical difficulties related to integration of many different pixels in an array format. Plasmonic metamaterial absorbers (PMAs) can impart wavelength or polarization selectivity to conventional thermal IR detectors simply by controlling the surface geometry of the absorbers to produce surface plasmon resonances at designed wavelengths or polarizations. This enables integration of many different pixels in an array format without any filters or polarizers. We review our recent advances in wavelength- and polarization-selective thermal IR sensors using PMAs for multi-color or polarimetric imaging. The absorption mechanism defined by the surface structures is discussed for three types of PMAs-periodic crystals, metal-insulator-metal and mushroom-type PMAs-to demonstrate appropriate applications. Our wavelength- or polarization-selective uncooled IR sensors using various PMAs and multi-color image sensors are then described. Finally, high-performance mushroom-type PMAs are investigated. These advanced functional thermal IR detectors with wavelength or polarization selectivity will provide great benefits for a wide range of applications.

21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). 170.103 Section 170.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Confidentiality of information in a premarket notification for a food contact substance (FCN). 170.102 Section 170.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD...

Predictive and External Validity of a Pre-Market Study to Determine the Most Effective Pictorial Health Warning Label Content for Cigarette Packages.

PubMed

Huang, Li-Ling; Thrasher, James F; Reid, Jessica L; Hammond, David

2016-05-01

Studies examining cigarette package pictorial health warning label (HWL) content have primarily used designs that do not allow determination of effectiveness after repeated, naturalistic exposure. This research aimed to determine the predictive and external validity of a pre-market evaluation study of pictorial HWLs. Data were analyzed from: (1) a pre-market convenience sample of 544 adult smokers who participated in field experiments in Mexico City before pictorial HWL implementation (September 2010); and (2) a post-market population-based representative sample of 1765 adult smokers in the Mexican administration of the International Tobacco Control Policy Evaluation Survey after pictorial HWL implementation. Participants in both samples rated six HWLs that appeared on cigarette packs, and also ranked HWLs with four different themes. Mixed effects models were estimated for each sample to assess ratings of relative effectiveness for the six HWLs, and to assess which HWL themes were ranked as the most effective. Pre- and post-market data showed similar relative ratings across the six HWLs, with the least and most effective HWLs consistently differentiated from other HWLs. Models predicting rankings of HWL themes in post-market sample indicated: (1) pictorial HWLs were ranked as more effective than text-only HWLs; (2) HWLs with both graphic and "lived experience" content outperformed symbolic content; and, (3) testimonial content significantly outperformed didactic content. Pre-market data showed a similar pattern of results, but with fewer statistically significant findings. The study suggests well-designed pre-market studies can have predictive and external validity, helping regulators select HWL content. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... data or other information available to FDA, including data not submitted by the manufacturer or...

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including data...

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including data...

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including data...

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including data...

A survey of Campylobacter and other bacterial contaminants of pre-market chicken and retail poultry and meats, King County, Washington.

PubMed Central

Harris, N V; Thompson, D; Martin, D C; Nolan, C M

1986-01-01

As part of a larger study to determine the flow of Campylobacter and Salmonella from food animals to humans during 1982-83, 1,936 swabs were collected for bacteriologic study from pre-market chickens, retail poultry, and other retail meats as well as from equipment and work surfaces used to process such foods. Of the 297 samples collected in a poultry processing plant, 56.6 per cent were positive for Campylobacter jejuni/coli (CJC), as were 23.1 per cent of the 862 retail chicken, and 17.2 per cent of the 29 retail game hen samples. CJC was found infrequently in retail turkey, pork, and beef samples. Contamination of retail and pre-market chicken with CJC appeared to increase as the week progressed, and in pre-market chicken, later in the day. Less than 5 per cent of the retail samples of poultry, beef, and pork were found to contain Yersinia or Salmonella. However, Salmonella was cultured from 14.8 per cent of the swabs taken from the processing plant with 68 per cent of 44 Salmonellas being isolated concurrently with CJC. Tetracycline resistance which was plasmid-mediated was the most common antibiotic resistance observed, and was carried by 23.8 per cent of all CJC isolates. Overall, 38.8 per cent of all CJC isolates were resistant to ampicillin, erythromycin, streptomycin, or tetracycline, either singly or in combination. PMID:3953916

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.

PubMed

Rathi, Vinay K; Wang, Bo; Ross, Joseph S; Downing, Nicholas S; Kesselheim, Aaron S; Gray, Stacey T

2017-02-01

The US Food and Drug Administration (FDA) approves high-risk medical devices based on premarket pivotal clinical studies demonstrating reasonable assurance of safety and effectiveness and may require postapproval studies (PAS) to further inform benefit-risk assessment. We conducted a cross-sectional analysis using publicly available FDA documents to characterize industry-sponsored pivotal studies and PAS of high-risk devices used in the treatment of otolaryngologic diseases. Between 2000 and 2014, the FDA approved 23 high-risk otolaryngologic devices based on 28 pivotal studies. Median enrollment was 118 patients (interquartile range, 67-181), and median duration of longest primary effectiveness end point follow-up was 26 weeks (interquartile range, 16-96). Fewer than half were randomized (n = 13, 46%), blinded (n = 12, 43%), or controlled (n = 10, 36%). The FDA required 23 PASs for 16 devices (70%): almost two-thirds (n = 15, 65%) monitored long-term performance, and roughly one-third (n = 8, 35%) focused on subgroups. Otolaryngologists should be aware of limitations in the strength of premarket evidence when considering the use of newly approved devices.

21 CFR 814.104 - Original applications.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Original applications. 814.104 Section 814.104...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.104 Original... applicant. (d) Address for submissions and correspondence. Copies of all original HDEs amendments and...

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

PubMed

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

FDA use of international standards in the premarket review process.

PubMed

Rechen, E; Barth, D J; Marlowe, D; Kroger, L

1998-01-01

"This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European

Wavelength- or Polarization-Selective Thermal Infrared Detectors for Multi-Color or Polarimetric Imaging Using Plasmonics and Metamaterials

PubMed Central

Ogawa, Shinpei; Kimata, Masafumi

2017-01-01

Wavelength- or polarization-selective thermal infrared (IR) detectors are promising for various novel applications such as fire detection, gas analysis, multi-color imaging, multi-channel detectors, recognition of artificial objects in a natural environment, and facial recognition. However, these functions require additional filters or polarizers, which leads to high cost and technical difficulties related to integration of many different pixels in an array format. Plasmonic metamaterial absorbers (PMAs) can impart wavelength or polarization selectivity to conventional thermal IR detectors simply by controlling the surface geometry of the absorbers to produce surface plasmon resonances at designed wavelengths or polarizations. This enables integration of many different pixels in an array format without any filters or polarizers. We review our recent advances in wavelength- and polarization-selective thermal IR sensors using PMAs for multi-color or polarimetric imaging. The absorption mechanism defined by the surface structures is discussed for three types of PMAs—periodic crystals, metal-insulator-metal and mushroom-type PMAs—to demonstrate appropriate applications. Our wavelength- or polarization-selective uncooled IR sensors using various PMAs and multi-color image sensors are then described. Finally, high-performance mushroom-type PMAs are investigated. These advanced functional thermal IR detectors with wavelength or polarization selectivity will provide great benefits for a wide range of applications. PMID:28772855

Mapping the properties of blue compact dwarf galaxies: integral field spectroscopy with PMAS

NASA Astrophysics Data System (ADS)

Cairós, L. M.; Caon, N.; Zurita, C.; Kehrig, C.; Roth, M.; Weilbacher, P.

2010-09-01

Context. Blue compact dwarf (BCD) galaxies are low-luminosity, low-metal content dwarf systems undergoing violent bursts of star formation. They present a unique opportunity to probe galaxy formation and evolution and to investigate the process of star formation in a relatively simple scenario. Spectrophotometric studies of BCDs are essential to disentangle and characterize their stellar populations. Aims: We perform integral field spectroscopy of a sample of BCDs with the aim of analyzing their morphology, the spatial distribution of some of their physical properties (excitation, extinction, and electron density) and their relationship with the distribution and evolutionary state of the stellar populations. Methods: Integral field spectroscopy observations of the sample galaxies were carried out with the Potsdam Multi-Aperture Spectrophotometer (PMAS) at the 3.5 m telescope at Calar Alto Observatory. An area 16 arcsec × 16 arcsec in size was mapped with a spatial sampling of 1 arcsec × 1 arcsec. We obtained data in the 3590-6996 Å spectral range, with a linear dispersion of 3.2 Å per pixel. From these data we built two-dimensional maps of the flux of the most prominent emission lines, of two continuum bands, of the most relevant line ratios, and of the gas velocity field. Integrated spectra of the most prominent star-forming regions and of whole objects within the FOV were used to derive their physical parameters and the gas metal abundances. Results: Six galaxies display the same morphology both in emission line and in continuum maps; only in two objects, Mrk 32 and Tololo 1434+032, the distributions of the ionized gas and of the stars differ considerably. In general the different excitation maps for a same object display the same pattern and trace the star-forming regions, as expected for objects ionized by hot stars; only the outer regions of Mrk 32, I Zw 123 and I Zw 159 display higher [S II]/Hα values, suggestive of shocks. Six galaxies display an

The practice of pre-marketing safety assessment in drug development.

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

Metal-Insulator-Metal-Based Plasmonic Metamaterial Absorbers at Visible and Infrared Wavelengths: A Review.

PubMed

Ogawa, Shinpei; Kimata, Masafumi

2018-03-20

Electromagnetic wave absorbers have been investigated for many years with the aim of achieving high absorbance and tunability of both the absorption wavelength and the operation mode by geometrical control, small and thin absorber volume, and simple fabrication. There is particular interest in metal-insulator-metal-based plasmonic metamaterial absorbers (MIM-PMAs) due to their complete fulfillment of these demands. MIM-PMAs consist of top periodic micropatches, a middle dielectric layer, and a bottom reflector layer to generate strong localized surface plasmon resonance at absorption wavelengths. In particular, in the visible and infrared (IR) wavelength regions, a wide range of applications is expected, such as solar cells, refractive index sensors, optical camouflage, cloaking, optical switches, color pixels, thermal IR sensors, IR microscopy and gas sensing. The promising properties of MIM-PMAs are attributed to the simple plasmonic resonance localized at the top micropatch resonators formed by the MIMs. Here, various types of MIM-PMAs are reviewed in terms of their historical background, basic physics, operation mode design, and future challenges to clarify their underlying basic design principles and introduce various applications. The principles presented in this review paper can be applied to other wavelength regions such as the ultraviolet, terahertz, and microwave regions.

Metal-Insulator-Metal-Based Plasmonic Metamaterial Absorbers at Visible and Infrared Wavelengths: A Review

PubMed Central

Ogawa, Shinpei; Kimata, Masafumi

2018-01-01

Electromagnetic wave absorbers have been investigated for many years with the aim of achieving high absorbance and tunability of both the absorption wavelength and the operation mode by geometrical control, small and thin absorber volume, and simple fabrication. There is particular interest in metal-insulator-metal-based plasmonic metamaterial absorbers (MIM-PMAs) due to their complete fulfillment of these demands. MIM-PMAs consist of top periodic micropatches, a middle dielectric layer, and a bottom reflector layer to generate strong localized surface plasmon resonance at absorption wavelengths. In particular, in the visible and infrared (IR) wavelength regions, a wide range of applications is expected, such as solar cells, refractive index sensors, optical camouflage, cloaking, optical switches, color pixels, thermal IR sensors, IR microscopy and gas sensing. The promising properties of MIM-PMAs are attributed to the simple plasmonic resonance localized at the top micropatch resonators formed by the MIMs. Here, various types of MIM-PMAs are reviewed in terms of their historical background, basic physics, operation mode design, and future challenges to clarify their underlying basic design principles and introduce various applications. The principles presented in this review paper can be applied to other wavelength regions such as the ultraviolet, terahertz, and microwave regions. PMID:29558454

Connecting pre-marketing clinical research and medical practice: opinion-based study of core issues and possible changes in drug regulation.

PubMed

Wieringa, Nicolien F; Peschar, Jules L; Denig, Petra; de Graeff, Pieter A; Vos, Rein

2003-01-01

To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for dosing this gap. Interviews with 47 physicians and pharmacists who were liaised to drug regulation through their role in the pre- and post-marketing shaping of new cardiovascular drugs. Data were analyzed using methods of grounded theory and analytical evaluations. Six core issues were identified that referred to the standards in drug regulation, the organization of the regulatory system, and conflicting interests. Pre-marketing trials should focus more on populations and research questions relevant to medical practice. In particular, variability in drug responses between subgroups of patients and demonstration of effectiveness should become major principles in drug regulation. An interactive post-marketing process in which public interests are represented was considered necessary to further guide research and development according to the needs in daily practice. Strategies for change could be applied within the present system of drug regulation, or affect its basic principles. Regulatory authorities were primarily identified to initiate changes, but many other parties should be involved. Barriers for change were identified regarding differences in interests between parties, organizational matters, and with respect to broader healthcare policies. Based on the respondents' opinions, there is a need to focus regulatory standards more on the needs in medical practice. Therefore, regulatory authorities should further develop their influence in the pre- and post-marketing drug development process, together with other parties involved, in order to bridge the gap between clinical research and medical practice.

International Space Station Environmental Control and Life Support System Acceptance Testing for the Pressurized Mating Adapters

NASA Technical Reports Server (NTRS)

Williams, David E.

2008-01-01

The International Space Station (ISS) Pressurized Mating Adapters (PMAs) Environmental Control and Life Support (ECLS) System is comprised of three subsystems: Atmosphere Control and Supply (ACS), Temperature and Humidity Control (THC), and Water Recovery and Management (WRM). PMAs 1 and 2 flew to ISS on Flight 2A and Pressurized Mating Adapter (PMA) 3 flew to ISS on Flight 3A. This paper provides a summary of the PMAs ECLS design and a detailed discussion of the ISS ECLS Acceptance Testing methodologies utilized for the PMAs.

Identifying poor metabolic adaptation during early lactation in dairy cows using cluster analysis.

PubMed

Tremblay, M; Kammer, M; Lange, H; Plattner, S; Baumgartner, C; Stegeman, J A; Duda, J; Mansfeld, R; Döpfer, D

2018-05-02

Currently, cows with poor metabolic adaptation during early lactation, or poor metabolic adaptation syndrome (PMAS), are often identified based on detection of hyperketonemia. Unfortunately, elevated blood ketones do not manifest consistently with indications of PMAS. Expected indicators of PMAS include elevated liver enzymes and bilirubin, decreased rumen fill, reduced rumen contractions, and a decrease in milk production. Cows with PMAS typically are higher producing, older cows that are earlier in lactation and have greater body condition score at the start of lactation. It was our aim to evaluate commonly used measures of metabolic health (input variables) that were available [i.e., blood β-hydroxybutyrate acid, milk fat:protein ratio, blood nonesterified fatty acids (NEFA)] to characterize PMAS. Bavarian farms (n = 26) with robotic milking systems were enrolled for weekly visits for an average of 6.7 wk. Physical examinations of the cows (5-50 d in milk) were performed by veterinarians during each visit, and blood and milk samples were collected. Resulting data included 790 observations from 312 cows (309 Simmental, 1 Red Holstein, 2 Holstein). Principal component analysis was conducted on the 3 input variables, followed by K-means cluster analysis of the first 2 orthogonal components. The 5 resulting clusters were then ascribed to low, intermediate, or high PMAS classes based on their degree of agreement with expected PMAS indicators and characteristics in comparison with other clusters. Results revealed that PMAS classes were most significantly associated with blood NEFA levels. Next, we evaluated NEFA values that classify observations into appropriate PMAS classes in this data set, which we called separation values. Our resulting NEFA separation values [<0.39 mmol/L (95% confidence limits = 0.360-0.410) to identify low PMAS observations and ≥0.7 mmol/L (95% confidence limits = 0.650-0.775) to identify high PMAS observations] were similar to values

Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest.

PubMed

Rothman, David J; McDonald, Walter J; Berkowitz, Carol D; Chimonas, Susan C; DeAngelis, Catherine D; Hale, Ralph W; Nissen, Steven E; Osborn, June E; Scully, James H; Thomson, Gerald E; Wofsy, David

2009-04-01

Professional medical associations (PMAs) play an essential role in defining and advancing health care standards. Their conferences, continuing medical education courses, practice guidelines, definitions of ethical norms, and public advocacy positions carry great weight with physicians and the public. Because many PMAs receive extensive funding from pharmaceutical and device companies, it is crucial that their guidelines manage both real and perceived conflict of interests. Any threat to the integrity of PMAs must be thoroughly and effectively resolved. Current PMA policies, however, are not uniform and often lack stringency. To address this situation, the authors first identified and analyzed conflicts of interest that may affect the activities, leadership, and members of PMAs. The authors then went on to formulate guidelines, both short-term and long-term, to prevent the appearance or reality of undue industry influence. The recommendations are rigorous and would require many PMAs to transform their mode of operation and perhaps, to forgo valuable activities. To maintain integrity, sacrifice may be required. Nevertheless, these changes are in the best interest of the PMAs, the profession, their members, and the larger society.

21 CFR 884.5320 - Glans sheath.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the entire shaft of the penis. It is indicated only for the prevention of pregnancy and not for the prevention of sexually-transmitted diseases. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is...

Haptic control of a pneumatic muscle actuator to provide resistance for simulated isokinetic exercise; part II: control development and testing.

PubMed

Hall, Kara L; Phillips, Chandler A; Reynolds, David B; Mohler, Stanley R; Rogers, Dana B; Neidhard-Doll, Amy T

2015-01-01

Pneumatic muscle actuators (PMAs) have a high power to weight ratio and possess unique characteristics which make them ideal actuators for applications involving human interaction. PMAs are difficult to control due to nonlinear dynamics, presenting challenges in system implementation. Despite these challenges, PMAs have great potential as a source of resistance for strength training and rehabilitation. The objective of this work was to control a PMA for use in isokinetic exercise, potentially benefiting anyone in need of optimal strength training through a joint's range of motion. The controller, based on an inverse three-element phenomenological model and adaptive nonlinear control, allows the system to operate as a type of haptic device. A human quadriceps dynamic simulator was developed (as described in Part I of this work) so that control effectiveness and accommodation could be tested prior to human implementation. Tracking error results indicate that the control system is effective at producing PMA displacement and resistance necessary for a scaled, simulated neuromuscular actuator to maintain low-velocity isokinetic movement during simulated concentric and eccentric knee extension.

77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-23

...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' FDA is issuing this guidance to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems.

77 FR 48160 - Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...] Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments... Cardiovascular Devices 30-Day Notices and Annual Reports.'' This public workshop will be cosponsored with... approval applications (PMAs), 30-day notices and annual reports, specifically for cardiovascular devices...

International Space Station Environmental Control and Life Support System: Verification for the Pressurized Mating Adapters

NASA Technical Reports Server (NTRS)

Williams, David E.

2007-01-01

The International Space Station (ISS) Pressurized Mating Adapters (PMAs) Environmental Control and Life Support (ECLS) System is comprised of three subsystems: Atmosphere Control and Supply (ACS), Temperature and Humidity Control (THC), and Water Recovery and Management (WRM). PMA 1 and PMA 2 flew to ISS on Flight 2A and PMA 3 flew to ISS on Flight 3A. This paper provides a summary of the PMAs ECLS design and the detailed Element Verification methodologies utilized during the Qualification phase for the PMAs.

Food and Drug Administration Regulation of in Vitro Diagnostic Devices

PubMed Central

Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.

2005-01-01

The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468

Pre-market version of a commercially available hearing instrument with a tinnitus sound generator: feasibility of evaluation in a clinical trial.

PubMed

Sereda, Magdalena; Davies, Jeff; Hall, Deborah A

2017-04-01

This report considers feasibility of conducting a UK trial of combination devices for tinnitus, using data from the study which evaluated different listener programmes available within the pre-market version of Oticon Alta with Tinnitus Sound Generator. Open and closed questions addressed the following feasibility issues: (1) Participant recruitment; (2) Device acceptability; (3) Programme preferences in different self-nominated listening situations; (4) Usability; (5) Compliance; (6) Adverse events. Eight current combination hearing aid users (all males) aged between 62-72 years (mean age 67.25 years, SD = 3.8). All eight participants reported the physical aspects and noise options on the experimental device to be acceptable. Programmes with amplification and masking features were equally preferred over the basic amplification-only programme. Individual preferences for the different programme options varied widely, both across participants and across listening situations. A set of recommendations for future trials were formulated which calls for more "real world" trial design rather than tightly controlling the fitting procedure.

Synthesis of sFlt-1 by platelet-monocyte aggregates contributes to the pathogenesis of preeclampsia

PubMed Central

Major, Heather D.; Cambell, Robert A.; Silver, Robert M.; Branch, D. Ware; Weyrich, Andrew S.

2014-01-01

Objective Soluble fms-like tyrosine kinase (sFlt-1) is an important mediator in the pathogenesis of preeclampsia. We sought to determine if platelet-monocyte aggregates (PMAs) produced sFlt-1 and if PMAs contributed to sFlt-1 production in preeclampsia. Study Design Case-control study of sFlt-1 release from PMAs using blood samples from women with preeclampsia matched by gestational age to pregnant controls. A third group of nonpregnant, reproductive-age women comprised an additional control group. Experiments were also performed using blood from non-pregnant women to elucidate if inducing PMAs could stimulate sFlt-1 production, and if so, to determine the necessary receptors and pathways. Results Women with preeclampsia had increased total Flt-1 concentrations in platelets and monocytes at baseline compared to pregnant controls (25 vs. 10 pg/ml, p=0.0003). sFlt-1 production was elicited from monocytes incubated with thrombin-activated platelets from non-pregnant women. sFlt-1 production was regulated at the transcriptional level by p38 and NF-κB dependent pathways. Conclusion Activated platelets in preeclampsia bind monocytes to generate sFlt-1. PMAs are a previously unrecognized source of sFlt-1 that may contribute to endothelial dysfunction and systemic inflammation commonly observed in preeclampsia. PMID:24440566

78 FR 65339 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... the applicant for marketing a particular medical device. A class III device that fails to meet PMA..., devices that were in commercial distribution before May 28, 1976, are not required to submit a PMA until... is labor-intensive to compile and complete; the remaining PMAs require minimal information. Based on...

Structural precaution: the application of premarket approval schemes in EU food legislation.

PubMed

van der Meulen, Bernd M J; Bremmers, Harry J; Wijnands, Jo H M; Poppe, Krijn J

2012-01-01

Structural precaution refers to legal requirements by which food products (whether as ingredients, additives, genetically modified or innovative in some other form) are only admitted to the market after authorization by public authorities and till then are presumed unsafe. In the EU such authorization is granted after provision of conclusive scientific evidence of the product's safety by the applicant. The objective of this article is to critically evaluate structural precaution in the EU against the general principles of European and international law. Moreover, it addresses the positive and negative side-effects of structural precaution for food businesses. The methods which are applied are legal-systematic and empirical. Legal-systematic research shows that the European system of structural precaution may come into conflict with the principles of free trade. Empirical research on the effects of structural precaution shows that the barriers to market access impede food innovations, negatively impact competitiveness, and induce opportunistic strategic responses by food businesses. Among the opportunistic strategic responses that were identified are window-dressing, trespassing and circumventing. These may have adverse effects on food safety. This is remarkable since food safety is the key driving force behind the application of structural precaution. The article advocates an overhaul of the present European risk prevention framework. It argues that the newly proposed European legal framework for innovative foods only partly addresses the identified problems with which the food industry is confronted. Supplementary to legal-systematic overhaul, authorities should invest in accessibility and transparency of the legal framework and provide compliance assistance to reduce regulatory burdens.

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In

78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-28

... research and marketing applications for medical devices. This draft guidance is not final nor is it in... FDA-regulated products (21 CFR 58.1). The draft guidance provides clarification on GLP terminology, the types of medical device research or marketing applications that are subject to the GLP regulation...

Tissue engineered constructs: perspectives on clinical translation.

PubMed

Lu, Lichun; Arbit, Harvey M; Herrick, James L; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J

2015-03-01

In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the U.S. Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or new drug application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented.

Tissue Engineered Constructs: Perspectives on Clinical Translation

PubMed Central

Lu, Lichun; Arbit, Harvey M.; Herrick, James L.; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J.

2015-01-01

In this article, a “bedside to bench and back” approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the US Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or New Drug Application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented. PMID:25711151

Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters

PubMed Central

Kumsa, Doe; Steinke, G. Karl; Molnar, Gregory F.; Hudak, Eric M.; Montague, Fred W.; Kelley, Shawn C.; Untereker, Darrel F.; Shi, Alan; Hahn, Benjamin P.; Condit, Chris; Lee, Hyowon; Bardot, Dawn; Centeno, Jose A.; Krauthamer, Victor; Takmakov, Pavel A.

2017-01-01

Objective The Shannon model is often used to define an expected boundary between non-damaging and damaging modes of electrical neurostimulation. Numerous preclinical studies have been performed by manufacturers of neuromodulation devices using different animal models and a broad range of stimulation parameters while developing devices for clinical use. These studies are mostly absent from peer-reviewed literature, which may lead to this information being overlooked by the scientific community. We aimed to locate summaries of these studies accessible via public regulatory databases and to add them to a body of knowledge available to a broad scientific community. Methods We employed web search terms describing device type, intended use, neural target, therapeutic application, company name, and submission number to identify summaries for premarket approval (PMA) devices and 510(k) devices. We filtered these records to a subset of entries that have sufficient technical information relevant to safety of neurostimulation. Results We identified 13 product codes for 8 types of neuromodulation devices. These led us to devices that have 22 PMAs and 154 510(k)s and six transcripts of public panel meetings. We found one PMA for a brain, peripheral nerve, and spinal cord stimulator and five 510(k) spinal cord stimulators with enough information to plot in Shannon coordinates of charge and charge density per phase. Conclusions Analysis of relevant entries from public regulatory databases reveals use of pig, sheep, monkey, dog, and goat animal models with deep brain, peripheral nerve, muscle and spinal cord electrode placement with a variety of stimulation durations (hours to years); frequencies (10–10,000 Hz) and magnitudes (Shannon k from below zero to 4.47). Data from located entries indicate that a feline cortical model that employs acute stimulation might have limitations for assessing tissue damage in diverse anatomical locations, particularly for peripheral nerve and

Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters.

PubMed

Kumsa, Doe; Steinke, G Karl; Molnar, Gregory F; Hudak, Eric M; Montague, Fred W; Kelley, Shawn C; Untereker, Darrel F; Shi, Alan; Hahn, Benjamin P; Condit, Chris; Lee, Hyowon; Bardot, Dawn; Centeno, Jose A; Krauthamer, Victor; Takmakov, Pavel A

2018-02-01

The Shannon model is often used to define an expected boundary between non-damaging and damaging modes of electrical neurostimulation. Numerous preclinical studies have been performed by manufacturers of neuromodulation devices using different animal models and a broad range of stimulation parameters while developing devices for clinical use. These studies are mostly absent from peer-reviewed literature, which may lead to this information being overlooked by the scientific community. We aimed to locate summaries of these studies accessible via public regulatory databases and to add them to a body of knowledge available to a broad scientific community. We employed web search terms describing device type, intended use, neural target, therapeutic application, company name, and submission number to identify summaries for premarket approval (PMA) devices and 510(k) devices. We filtered these records to a subset of entries that have sufficient technical information relevant to safety of neurostimulation. We identified 13 product codes for 8 types of neuromodulation devices. These led us to devices that have 22 PMAs and 154 510(k)s and six transcripts of public panel meetings. We found one PMA for a brain, peripheral nerve, and spinal cord stimulator and five 510(k) spinal cord stimulators with enough information to plot in Shannon coordinates of charge and charge density per phase. Analysis of relevant entries from public regulatory databases reveals use of pig, sheep, monkey, dog, and goat animal models with deep brain, peripheral nerve, muscle and spinal cord electrode placement with a variety of stimulation durations (hours to years); frequencies (10-10,000 Hz) and magnitudes (Shannon k from below zero to 4.47). Data from located entries indicate that a feline cortical model that employs acute stimulation might have limitations for assessing tissue damage in diverse anatomical locations, particularly for peripheral nerve and spinal cord simulation. © 2017

Incidence and Antimicrobial Susceptibility to Clostridium perfringens in Premarket Broilers in Taiwan.

PubMed

Fan, Yang-Chi; Wang, Chia-Lan; Wang, Chinling; Chen, Tsung-Cheng; Chou, Chung-Hsi; Tsai, Hsiang-Jung

2016-06-01

Clostridium perfringens infection causes subclinical and clinical necrotic enteritis in poultry flocks, and it is estimated to result in US$2 billion of losses worldwide every year. The aims of this study were to determine the incidence, toxin types, and antimicrobial resistance levels to C. perfringens isolated from premarket, 5-wk-old, clinically healthy broiler chickens in Taiwan, and to examine the relationships between intestinal lesions and the numbers of C. perfringens in intestinal contents. In total, 435 samples of chicken ileum contents were collected from 98 broiler farms during June 2012 to February 2013. The C. perfringens isolation rate was 9.9% (43/435). The positive rate of tested farms was 29.6% (29/98). All the isolates were C. perfringens type A, only possessing the cpa gene encoding for toxin α. No netB gene encoding NetB toxin associated with necrotic enteritis, and no cpe gene encoding for the C. perfringens enterotoxin causing human intestinal disorder were detected. A quantitative PCR analysis revealed that the mean C. perfringens number in the intestinal contents was 3.9 × 10(6) colony-forming units (CFU)/g, ranging from 6.85 × 10(2) to 1.61 × 10(7) CFU/g. The gross and histopathologic lesions revealed a positive correlation (p < 0.05) between lesion score and C. perfringens number in the ilea of C. perfringens -positive chickens. Antimicrobial susceptibility tests of all C. perfringens isolates indicated that the minimum inhibitory concentration inhibiting 50% of isolates (MIC50) for amoxicillin, bacitracin, chlortetracycline, enrofloxacin, erythromycin, florfenicol, and lincomycin was ≤0.125, 0.5, 128, 0.25, ≥256, 2, and ≥256 μg/ml, respectively. Most of the C. perfringens isolates were susceptible to amoxicillin, bacitracin, and enrofloxacin but resistant to chlortetracycline, erythromycin, and lincomycin. Interestingly, C. perfringens isolated from chickens with severe lesions had higher MIC50 for erythromycin and lincomycin

Compendium of GAO’s Views on the Cost Saving Proposals of the Grace Commission. Volume 1. Summary of Findings.

DTIC Science & Technology

1985-02-19

effort to develop a govern- ment-wide integrated financial management structure. Such an effort must have a solid base of fundamental concepts to guide ...initiatives address many PPSSCC debt collection concerns The PPSSCC recommendations basically parallel our prior *- recommendations and ongoing OMB...PPSSCC recommended either selling the PMAs’ facilities or adjusting the PMAs’ user fees, ratemaking process, and pricina structure. In total, the PPSSCC

76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.

Prediction of multiple resonance characteristics by an extended resistor-inductor-capacitor circuit model for plasmonic metamaterials absorbers in infrared.

PubMed

Xu, Xiaolun; Li, Yongqian; Wang, Binbin; Zhou, Zili

2015-10-01

The resonance characteristics of plasmonic metamaterials absorbers (PMAs) are strongly dependent on geometric parameters. A resistor-inductor-capacitor (RLC) circuit model has been extended to predict the resonance wavelengths and the bandwidths of multiple magnetic polaritons modes in PMAs. For a typical metallic-dielectric-metallic structure absorber working in the infrared region, the developed model describes the correlation between the resonance characteristics and the dimensional sizes. In particular, the RLC model is suitable for not only the fundamental resonance mode, but also for the second- and third-order resonance modes. The prediction of the resonance characteristics agrees fairly well with those calculated by the finite-difference time-domain simulation and the experimental results. The developed RLC model enables the facilitation of designing multi-band PMAs for infrared radiation detectors and thermal emitters.

78 FR 59008 - Grant of Interim Extension of the Term of U.S. Patent No. 5,454,779; ResQPump®/ResQPOD® ITD

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-25

... of the application indicates that, except for permission to market or use the product commercially... University of California timely filed an application under 35 U.S.C. 156(d)(5) for a second interim extension... connection with the ResQPOD[supreg] ITD. The application indicates that a Premarket Approval Application, PMA...

21 CFR 20.100 - Applicability; cross-reference to other regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of this chapter. (25) Cosmetic establishment registrations, in § 710.7 of this chapter. (26) Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter. (27) Cosmetic product experience reports, in § 730.7 of this chapter. (28) Device premarket notification...

21 CFR 20.100 - Applicability; cross-reference to other regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of this chapter. (25) Cosmetic establishment registrations, in § 710.7 of this chapter. (26) Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter. (27) Cosmetic product experience reports, in § 730.7 of this chapter. (28) Device premarket notification...

77 FR 73034 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-07

... recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace Responsive Neurostimulation (RNS) System sponsored by NeuroPace, Inc. The RNS System is indicated for use as...

Comparing parents' and overweight adolescents' reports on parent mealtime actions.

PubMed

Volpe, Carolina Bertagnoli; Petty, Maria Luiza Blanques; de Souza, Altay Alves Lino; Escrivão, Maria Arlete Meil Schimith

2018-01-01

This study aimed to compare answers given by parents and their adolescent children to the Portuguese version of the Parent Mealtime Action Scale (PMAS) and to assess associations among the reported behaviors. To compare these answers, a cross-sectional study was conducted in a sample of 72 patients of the Obesity Clinic of the Division of Nutrology of the Pediatrics Department at the Federal University of São Paulo (Unifesp), Brazil. These patients were aged from 10 years to 19 years and 11 months, and their parents or legal guardians also participated. First, parents were interviewed and instructed to answer how often they perform each behavior measured by the PMAS (never, sometimes or always). Next, the same questions were answered by the adolescents. The general linear model (GLM) showed the effects of the interviewees and of the interaction between interviewees and sex. We also observed a triple interaction effect (sex x interviewees x categorized age). The internal reliability of the PMAS was higher for parental answers than for those given by the children. This finding is probably observed because the scale has been developed and validated to evaluate the pattern of parental responses concerning their eating practices during their children's meals. In addition, although parents believe they are engaging in certain behaviors, the effectiveness of these strategies may not be recognized by their children. Very low intraclass correlation coefficients were observed between parents' and children's answers to the original domains of the PMAS (ICC: 0.130-0.578), suggesting that the factorial structure of the PMAS may only be used to assess parental behavior, as it is not sufficiently accurate to assess the children's understanding of parent mealtime actions. Copyright © 2017 Elsevier Ltd. All rights reserved.

78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... recommendations, and vote on information regarding the premarket approval (PMA) application for the Nucleus[supreg... Nucleus[supreg] Hybrid TM L24 Implant System (as stated in the PMA) is as follows: The Nucleus[supreg...

76 FR 17422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

..., and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without...

78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-18

... Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions--0910-NEW...

Hippo/YAP-mediated rigidity-dependent motor neuron differentiation of human pluripotent stem cells

NASA Astrophysics Data System (ADS)

Sun, Yubing; Yong, Koh Meng Aw; Villa-Diaz, Luis G.; Zhang, Xiaoli; Chen, Weiqiang; Philson, Renee; Weng, Shinuo; Xu, Haoxing; Krebsbach, Paul H.; Fu, Jianping

2014-06-01

Our understanding of the intrinsic mechanosensitive properties of human pluripotent stem cells (hPSCs), in particular the effects that the physical microenvironment has on their differentiation, remains elusive. Here, we show that neural induction and caudalization of hPSCs can be accelerated by using a synthetic microengineered substrate system consisting of poly(dimethylsiloxane) micropost arrays (PMAs) with tunable mechanical rigidities. The purity and yield of functional motor neurons derived from hPSCs within 23 days of culture using soft PMAs were improved more than fourfold and tenfold, respectively, compared with coverslips or rigid PMAs. Mechanistic studies revealed a multi-targeted mechanotransductive process involving Smad phosphorylation and nucleocytoplasmic shuttling, regulated by rigidity-dependent Hippo/YAP activities and actomyosin cytoskeleton integrity and contractility. Our findings suggest that substrate rigidity is an important biophysical cue influencing neural induction and subtype specification, and that microengineered substrates can thus serve as a promising platform for large-scale culture of hPSCs.

21 CFR 814.40 - Time frames for reviewing a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames for... the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order...

21 CFR 814.40 - Time frames for reviewing a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames for... the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order...

21 CFR 814.40 - Time frames for reviewing a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.40 Time frames for... the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order...

A critical first assessment of the new pre-market approval regime for new psychoactive substances (NPS) in New Zealand.

PubMed

Wilkins, Chris

2014-10-01

New Zealand has recently attempted to address the underlying drivers of the escalating new psychoactive substances (NPS) ('legal highs') problem by establishing the world's first pre-market approval regulatory regime for NPS. NPS products which can be shown with clinical trial data to pose a 'low risk' of harm will be approved for legal manufacture and sale. This paper critically assesses the new regime, drawing on experience of the pharmaceutical sector and legal BZP market. A number of characteristics of the recreational use of NPS may not be well addressed by standard medical clinical trials, including binge use, polydrug use, use by vulnerable groups and high-risk modes of administration. The overt advertising and covert promotion of approved NPS products on the internet may make them fairly visible to young people. The black market for unapproved NPS may be difficult to suppress given that unapproved NPS will be physically identical to approved NPS. If the legal market for NPS encourages the use of NPS, alcohol and other drugs there may be an increase in drug-related harm. Alternatively, if the legal NPS market reduces the use of more harmful drugs, there may be a considerable public health benefit. The clinical trials required for NPS products should address the characteristics of recreational NPS use. Enforcement resources and technical solutions are required to clearly distinguish legal NPS products. The impact the new NPS regime has on other drug use is a key issue and demands further study. © 2014 Society for the Study of Addiction.

21 CFR 814.42 - Filing a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.42 Filing a PMA. (a) The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within 45 days after a PMA is received by FDA, the agency will notify the...

21 CFR 814.42 - Filing a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

... PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.42 Filing a PMA. (a) The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within 45 days after a PMA is received by FDA, the agency will notify the...

21 CFR 814.42 - Filing a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

... PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.42 Filing a PMA. (a) The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within 45 days after a PMA is received by FDA, the agency will notify the...

Marketing HPV vaccine: implications for adolescent health and medical professionalism.

PubMed

Rothman, Sheila M; Rothman, David J

2009-08-19

The new vaccine against 4 types of human papillomavirus (HPV), Gardasil, like other immunizations appears to be a cost-effective intervention with the potential to enhance both adolescent health and the quality of their adult lives. However, the messages and the methods by which the vaccine was marketed present important challenges to physician practice and medical professionalism. By making the vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the subpopulations most at risk practically ignored. The vaccine manufacturer also provided educational grants to professional medical associations (PMAs) concerned with adolescent and women's health and oncology. The funding encouraged many PMAs to create educational programs and product-specific speakers' bureaus to promote vaccine use. However, much of the material did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits. As important and appropriate as it is for PMAs to advocate for vaccination as a public good, their recommendations must be consistent with appropriate and cost-effective use.

78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who... premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure... placed in the left atrial appendage. This device is intended to prevent thrombus embolization from the...

75 FR 4407 - The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-27

... premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic...-onset seizures (affecting only a part of the brain when they begin), with or without secondary... a partial-onset seizure that later spreads to the whole brain. ``Refractory'' to antiepileptic...

75 FR 47599 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... premarket notification and review process. FDA's regulations governing application for agency approval to...-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each... collection of information, before submitting the collection to OMB for approval. To comply with this...

Boeing technicians join Node 1 for ISS to PMA-1 in the SSPF

NASA Technical Reports Server (NTRS)

1997-01-01

Boeing technicians join Node 1 for the International Space Station (ISS) with the Pressurized Mating Adapter (PMA)-1 in KSC's Space Station Processing Facility. This PMA, identifiable by its bright red ring, is a cone-shaped connector for the space station's structural building block, known as Node 1. Seen here surrounded by scaffolding, Node 1 will have two PMAs attached, the second of which is scheduled for mating to the node in January 1998. The node and PMAs, which will be the first element of the ISS, are scheduled to be launched aboard the Space Shuttle Endeavour on STS-88 in July 1998.

78 FR 25746 - Agency Information Collection Activities; Proposed Collection; Comment Request; Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0380...: Assignment of Agency Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public...

75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... appropriate advisory committee hot line/ phone line to learn about possible modifications before coming to the... premarket approval application for the Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic, Inc. The Selenia C Digital Breast Tomosynthesis System is intended for use in the same clinical...

76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease. FDA intends to make background material available to the public no later than 2 business...

Surgical and clinical aspects of cerebellar pilomyxoid-spectrum astrocytomas in children.

PubMed

El Beltagy, Mohamed A; Atteya, Mostafa M E; El-Haddad, Alaa; Awad, Madiha; Taha, Hala; Kamal, Mohamed; El Naga, Sherif Abou

2014-06-01

Cerebellar pilomyxoid astrocytomas (PMAs) and intermediate pilomyxoid astrocytomas (IPAs) are collectively called "pilomyxoid-spectrum astrocytomas (PMSAs)." Cerebellar PMSAs are thought to behave more aggressively than pilocytic astrocytomas (PAs). Our objective is to compare PMSAs to PAs in terms of surgical and clinical profiles. This retrospective study included 66 cases (35 males and 31 females) with cerebellar astrocytomas treated between July 2007 and December 2012 at Children's Cancer Hospital Egypt (CCHE 57357) with a mean age of 7 (±1.5) years. Cases were divided into three subgroups as follows: 44 PAs, 10 IPAs, and 12 PMAs. Comparison between all groups was focusing on brain stem invasion, intrinsic necrotic cavitation, extent of resection, recurrence, leptomeningeal dissemination (LD), metastases, need for CSF diversion, and cerebellar mutism (CM). Cerebellar PMAs and IPAs separately and collectively had higher incidence of brain stem invasion, intrinsic necrotic cavitation, tumor recurrence, and LD when compared to PAs (P < 0.001). Gross total resection was 13.6 % in PMSAs versus 90.9 % in PAs (P < 0.001). PMAs had a higher incidence of tumor recurrence than IPAs (66.7 versus 20 %, P < 0.001). Incidence of recurrence in PAs was 9.1 % in partially resected cases. Mean interval to recurrence was 9 (±1.5) months in PMSAs and 42 (±2) months in PAs. Cerebellar PMSAs express an aggressive clinical behavior and impose more operative challenges than PAs. These tumors may represent a clinical spectrum-at its benign end lies PA, while PMA lies at the aggressive end, with IPA lying just behind. Such concepts could be used to guide management in the future.

75 FR 36102 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

... will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the... characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays...

76 FR 71980 - SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Incorporated's...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... Device and Radiological Health's (CDRH's) denial of a premarket approval application (PMA) for the... Committee: To provide advice and recommendations to the Agency on scientific disputes between CDRH and... EES and CDRH may be made to the docket on or before December 7, 2011. Submit electronic comments to...

Remedial Investigation Concept Plan for Picatinny Arsenal. Volume 1. Environmental Setting, Applicable Regulations, Summaries of Site Sampling Plans, Sampling Priorities, and Supporting Appendixes

DTIC Science & Technology

1991-03-22

Ortho additive -- (80%) 40 gal June 1988 inventory 8aygon Propoxur (2%) 13.5 lb Sevin Carbaryl (80%) 38 lb Pyrethrins Pyrethrins (1%) 33 lb Killmaster...4 20 cans + 2.5 gal P.M.A.S. 9.5 gal Manzate 200F 7 cans + I gal Insecticides Carbaryl 4L 7 cans Proxol 80SP 1 can Oiazinon 2 gal Dursban 11 gal...1.92%) 25 cans Treflan Trifluralin (--) 70 lb Abate 4E Temephos (43%) I gal Baygon Propoxur (14.6%) 8 gal Combat ant baits Hydramethylnon (0.9%) 852

21 CFR 3.3 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Scope. 3.3 Section 3.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.3 Scope. This section applies to: (a) Any...

21 CFR 3.3 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Scope. 3.3 Section 3.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.3 Scope. This section applies to: (a) Any...

21 CFR 3.3 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Scope. 3.3 Section 3.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.3 Scope. This section applies to: (a) Any...

21 CFR 3.3 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Scope. 3.3 Section 3.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.3 Scope. This section applies to: (a) Any...

21 CFR 814.15 - Research conducted outside the United States.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Research conducted outside the United States. 814... SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.15 Research... paragraph (b) or (c) of this section, as applicable. (b) Research begun on or after effective date. FDA will...

The benefits of the 3T3 NRU test in the safety assessment of cosmetics: long-term experience from pre-marketing testing in the Czech Republic.

PubMed

Jírová, D; Kejlová, K; Brabec, M; Bendová, H; Kolárová, H

2003-01-01

We have introduced the 3T3 NRU cytotoxicity test for methodological, economical and ethical reasons as a regular part of tier pre-marketing testing to assess local tolerance of raw materials for cosmetics, household chemicals and final cosmetic products. Using the 3T3 cell line according to the standard INVITTOX protocol No.64 (NRU Assay) the borderline concentration, relevant to the highest tolerated dose, is determined for each material. The toxic effect is reached at different concentration levels specific for individual cosmetics categories, depending on their chemical characteristics. Typical ranges of cytotoxicity for specific categories of cosmetics were established after testing of hundreds of materials. The range lies between 1 microg/ml (anti-dandruff shampoos), up to 2000 microg/ml (toothpastes and mouthwashes). The 3T3 NRU cytotoxicity test is a sensitive tool able to identify more aggressive products, that are also more likely to evoke irritation in human skin. It was even possible to detect protective effects of one natural herbal ingredient. The comparative study of cytotoxicity test results and human patch test results from a group of essential oils is presented. Cytotoxicity tests represent a highly ethical approach for estimation of irritancy. On the basis of in vitro test results suggesting low risk we can proceed to confirmatory tests in human volunteers.

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1998-05-18

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.

21 CFR 3.4 - Designated agency component.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Designated agency component. 3.4 Section 3.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.4 Designated agency component. (a) To designate the agency component...

21 CFR 3.4 - Designated agency component.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Designated agency component. 3.4 Section 3.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.4 Designated agency component. (a) To designate the agency component...

21 CFR 3.4 - Designated agency component.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Designated agency component. 3.4 Section 3.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.4 Designated agency component. (a) To designate the agency component...

21 CFR 3.4 - Designated agency component.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Designated agency component. 3.4 Section 3.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications § 3.4 Designated agency component. (a) To designate the agency component...

21 CFR 814.45 - Denial of approval of a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the... information before the agency, FDA determines that any of the grounds for denying approval of a PMA specified...

21 CFR 814.45 - Denial of approval of a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the... information before the agency, FDA determines that any of the grounds for denying approval of a PMA specified...

21 CFR 814.45 - Denial of approval of a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a PMA. (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the... information before the agency, FDA determines that any of the grounds for denying approval of a PMA specified...

77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-10

...] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray... guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft... premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA...

VizieR Online Data Catalog: Radial velocities in M3, M13, and M92 (Kamann+, 2014)

NASA Astrophysics Data System (ADS)

Kamann, S.; Wisotzki, L.; Roth, M. M.; Gerssen, J.; Husser, T.-O.; Sandin, C.; Weilbacher, P.

2014-04-01

Radial velocity data are presented for three Galactic globular clusters, M3, M13, and M92. The provided catalogues include several hundreds of stars in each cluster that cover a wide range of distances to the cluster centres. Besides the measured radial velocities, the catalogues contain measurement uncertainties, identifiers, world coordinates and variability information for each star. The velocities for stars near the centres of the clusters were obtained using PMAS integral field spectroscopy (IFS). Note that in order to facilitate future variability studies, for each star the individual velocity measurements are provided instead of a single combined velocity. The PMAS data are complemented with velocities reported in various literature studies for stars at larger distances to the centres. (6 data files).

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

PubMed

Kondo, Hideyuki; Saint-Raymond, Agnès; Yasuda, Naoyuki

2018-03-01

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.

77 FR 2552 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substances...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348) establishes a premarket approval... statutory premarket approval requirements based on a determination that such use is GRAS. The proposed... GRAS determination, and the notifier would maintain a record of such data and information. FDA would...

Identification of watershed priority management areas under water quality constraints: A simulation-optimization approach with ideal load reduction

NASA Astrophysics Data System (ADS)

Dong, Feifei; Liu, Yong; Wu, Zhen; Chen, Yihui; Guo, Huaicheng

2018-07-01

Targeting nonpoint source (NPS) pollution hot spots is of vital importance for placement of best management practices (BMPs). Although physically-based watershed models have been widely used to estimate nutrient emissions, connections between nutrient abatement and compliance of water quality standards have been rarely considered in NPS hotspot ranking, which may lead to ineffective decision-making. It's critical to develop a strategy to identify priority management areas (PMAs) based on water quality response to nutrient load mitigation. A water quality constrained PMA identification framework was thereby proposed in this study, based on the simulation-optimization approach with ideal load reduction (ILR-SO). It integrates the physically-based Soil and Water Assessment Tool (SWAT) model and an optimization model under constraints of site-specific water quality standards. To our knowledge, it was the first effort to identify PMAs with simulation-based optimization. The SWAT model was established to simulate temporal and spatial nutrient loading and evaluate effectiveness of pollution mitigation. A metamodel was trained to establish a quantitative relationship between sources and water quality. Ranking of priority areas is based on required nutrient load reduction in each sub-watershed targeting to satisfy water quality standards in waterbodies, which was calculated with genetic algorithm (GA). The proposed approach was used for identification of PMAs on the basis of diffuse total phosphorus (TP) in Lake Dianchi Watershed, one of the three most eutrophic large lakes in China. The modeling results demonstrated that 85% of diffuse TP came from 30% of the watershed area. Compared with the two conventional targeting strategies based on overland nutrient loss and instream nutrient loading, the ILR-SO model identified distinct PMAs and narrowed down the coverage of management areas. This study addressed the urgent need to incorporate water quality response into PMA

Boeing technicians discuss mating PMA-2 to Node 1 in the SSPF as STS-88 launch preparations continue

NASA Technical Reports Server (NTRS)

1998-01-01

Boeing technicians discuss mating Pressurized Mating Adapter (PMA)-2 to Node 1 of the International Space Station (ISS) in KSC's Space Station Processing Facility (SSPF). The node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS-88 later this year, along with PMAs 1 and 2. This PMA is a cone-shaped connector to Node 1, which will have two PMAs attached once this mate is completed. Once in space, Node 1 will function as a connecting passageway to the living and working areas of the ISS. It has six hatches that will serve as docking ports to the U.S. laboratory module, U.S. habitation module, an airlock and other space station elements.

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1991-10-10

The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.

Impact of polymer modification on mechanical and viscoelastic properties.

DOT National Transportation Integrated Search

2015-10-01

This study was initiated with the aim of evaluating the relative impact of different cross-linking agents : on the rheological and morphological properties of polymer modified asphalt binders (PMAs). To : complete this objective, two cross-linking ag...

21 CFR 807.93 - Content and format of a 510(k) statement.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

21 CFR 807.93 - Content and format of a 510(k) statement.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

21 CFR 807.93 - Content and format of a 510(k) statement.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

21 CFR 807.93 - Content and format of a 510(k) statement.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

21 CFR 807.93 - Content and format of a 510(k) statement.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Content and format of a 510(k) statement. 807.93... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I...

PMA-2 is in the process of being mated to Node 1 in the SSPF as STS-88 launch preparations continue

NASA Technical Reports Server (NTRS)

1998-01-01

Pressurized Mating Adapter (PMA)-2 is in the process of being mated to Node 1 of the International Space Station (ISS) under the supervision of Boeing technicians in KSC's Space Station Processing Facility (SSPF). The node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS- 88 later this year, along with PMAs 1 and 2. This PMA is a cone- shaped connector to Node 1, which will have two PMAs attached once this mate is completed. Once in space, Node 1 will function as a connecting passageway to the living and working areas of the ISS. It has six hatches that will serve as docking ports to the U.S. laboratory module, U.S. habitation module, an airlock and other space station elements.

KSC-98pc592

NASA Image and Video Library

1998-05-05

Pressurized Mating Adapter (PMA)-2 is in the process of being mated to Node 1 of the International Space Station (ISS) under the supervision of Boeing technicians in KSC's Space Station Processing Facility (SSPF). The node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS-88 later this year, along with PMAs 1 and 2. This PMA is a cone-shaped connector to Node 1, which will have two PMAs attached once this mate is completed. Once in space, Node 1 will function as a connecting passageway to the living and working areas of the ISS. It has six hatches that will serve as docking ports to the U.S. laboratory module, U.S. habitation module, an airlock and other space station elements

Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.

PubMed

Gopal, Anand D; Rathi, Vinay K; Teng, Christopher C; Del Priore, Lucian; Ross, Joseph S

2017-08-01

To characterize the frequency, nature, and regulatory mechanisms by which ophthalmic devices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (PMA). Retrospective cross-sectional analysis using publicly available FDA data. Ophthalmic devices initially approved via the FDA's PMA pathway between January 1, 1979 and December 31, 2015. We used the FDA's PMA Database to identify and characterize initial approvals and subsequent postmarket modifications to Class III ophthalmic devices. The FDA Recalls Database was used to identify associated safety events. Median iterated life span (timespan across which modifications occurred after initial PMA) and median number of supplements approved per device, by device type, and overall, stratified by regulatory pathway and modification type. Between 1979 and 2015, the FDA approved 168 original ophthalmic devices via the PMA pathway and 2813 subsequent modifications. More than one third (n = 64; 38%) of original approvals were intraocular lenses. Overall, devices underwent a median of 11 postmarket modifications (interquartile range [IQR], 3-24.8) across a median 10.0-year iterated life span (IQR, 4.1-16.7). The majority of devices (n = 144; 86%) underwent more than 1 postapproval modification, including more than 1 design modification (n = 84; 50%). The median number of changes altering device design or labeling was 3.5 (IQR, 1-9). Although manufacturing alterations (n = 834 of 2813; 30%) were the most frequent type of revision, changes involving device design (n = 667; 24%) and labeling (n = 417; 15%) were common. Recalled devices underwent more frequent postapproval modifications per year (median, 1.4; IQR, 0.7-2.3; mean, 1.5; 95% confidence interval, 1.1-1.9) in the period preceding recall than did nonrecalled devices (median, 0.5; IQR, 0.2-1.1; mean, 0.8; 95% confidence interval, 0.7-1.0) across their market approval period (P < 0.001). Most ophthalmic devices approved via the

Delegations of authority and organization; Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research--FDA. Final rule.

PubMed

1991-11-21

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to premarket approval of products that are or contain a biologic, a device, or a drug. The amendment grants directors, deputy directors, and certain other supervisory personnel in the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) reciprocal premarket approval authority to approve such products.

76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

PubMed

Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

Reactive underwater object inspection based on artificial electric sense.

PubMed

Lebastard, Vincent; Boyer, Frédéric; Lanneau, Sylvain

2016-07-26

Weakly electric fish can perform complex cognitive tasks based on extracting information from blurry electric images projected from their immediate environment onto their electro-sensitive skin. In particular they can be trained to recognize the intrinsic properties of objects such as their shape, size and electric nature. They do this by means of novel perceptual strategies that exploit the relations between the physics of a self-generated electric field, their body morphology and the ability to perform specific movement termed probing motor acts (PMAs). In this article we artificially reproduce and combine these PMAs to build an autonomous control strategy that allows an artificial electric sensor to find electrically contrasted objects, and to orbit around them based on a minimum set of measurements and simple reactive feedback control laws of the probe's motion. The approach does not require any simulation models and could be implemented on an autonomous underwater vehicle (AUV) equipped with artificial electric sense. The AUV has only to satisfy certain simple geometric properties, such as bi-laterally (left/right) symmetrical electrodes and possess a reasonably high aspect (length/width) ratio.

Unity with PMA-2 attached awaits further processing in the SSPF

NASA Technical Reports Server (NTRS)

1998-01-01

The International Space Station's (ISS) Unity node, with Pressurized Mating Adapter (PMA)-2 attached, awaits further processing by Boeing technicians in its workstand in the Space Station Processing Facility (SSPF). The Unity node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS-88 later this year. Unity has two PMAs attached to it now that this mate is completed. PMAs are conical docking adapters which will allow the docking systems used by the Space Shuttle and by Russian modules to attach to the node's hatches and berthing mechanisms. Once in orbit, Unity, which has six hatches, will be mated with the already orbiting Control Module and will eventually provide attachment points for the U.S. laboratory module; Node 3; an early exterior framework or truss for the station; an airlock; and a multi-windowed cupola. The Control Module, or Functional Cargo Block, is a U.S.-funded and Russian-built component that will be launched aboard a Russian rocket from Kazakstan.

Unity with PMA-2 attached awaits further processing in the SSPF

NASA Technical Reports Server (NTRS)

1998-01-01

The International Space Station's (ISS) Unity node, with Pressurized Mating Adapter (PMA)-2 attached, awaits further processing in the Space Station Processing Facility (SSPF). The Unity node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS-88 later this year. Unity has two PMAs attached to it now that this mate is completed. PMAs are conical docking adapters which will allow the docking systems used by the Space Shuttle and by Russian modules to attach to the node's hatches and berthing mechanisms. Once in orbit, Unity, which has six hatches, will be mated with the already orbiting Control Module and will eventually provide attachment points for the U.S. laboratory module; Node 3; an early exterior framework or truss for the station; an airlock; and a multi-windowed cupola. The Control Module, or Functional Cargo Block, is a U.S.- funded and Russian-built component that will be launched aboard a Russian rocket from Kazakstan.

KSC-98pc644

NASA Image and Video Library

1998-05-22

KENNEDY SPACE CENTER, FLA. -- The International Space Station's (ISS) Unity node, with Pressurized Mating Adapter (PMA)-2 attached, awaits further processing in the Space Station Processing Facility (SSPF). The Unity node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS-88 later this year. Unity has two PMAs attached to it now that this mate is completed. PMAs are conical docking adapters which will allow the docking systems used by the Space Shuttle and by Russian modules to attach to the node's hatches and berthing mechanisms. Once in orbit, Unity, which has six hatches, will be mated with the already orbiting Control Module and will eventually provide attachment points for the U.S. laboratory module; Node 3; an early exterior framework or truss for the station; an airlock; and a multi-windowed cupola. The Control Module, or Functional Cargo Block, is a U.S.-funded and Russian-built component that will be launched aboard a Russian rocket from Kazakstan

KSC-98pc645

NASA Image and Video Library

1998-05-22

KENNEDY SPACE CENTER, FLA. -- The International Space Station's (ISS) Unity node, with Pressurized Mating Adapter (PMA)-2 attached, awaits further processing in the Space Station Processing Facility (SSPF). The Unity node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS-88 later this year. Unity has two PMAs attached to it now that this mate is completed. PMAs are conical docking adapters which will allow the docking systems used by the Space Shuttle and by Russian modules to attach to the node's hatches and berthing mechanisms. Once in orbit, Unity, which has six hatches, will be mated with the already orbiting Control Module and will eventually provide attachment points for the U.S. laboratory module; Node 3; an early exterior framework or truss for the station; an airlock; and a multi-windowed cupola. The Control Module, or Functional Cargo Block, is a U.S.-funded and Russian-built component that will be launched aboard a Russian rocket from Kazakstan

US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016.

PubMed

Rathi, Vinay K; Gadkaree, Shekhar K; Ross, Joseph S; Kozin, Elliott D; Sethi, Rosh K; Naunheim, Matthew R; Puram, Sidharth V; Gray, Stacey T

2017-10-01

Objective The US Food and Drug Administration (FDA) clears moderate-risk devices via the 510(k) process based on substantial equivalence to previously cleared devices; evidence of safety and effectiveness is not required. We characterized the premarket evidence supporting FDA clearance of otolaryngologic devices. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects and Methods Recently cleared (1997-2016) moderate-risk otolaryngologic devices were categorized by type (diagnostic/therapeutic), subspecialty, implantable designation (yes/no), and recall history (yes/no). Supporting evidence was categorized by type (clinical/nonclinical/none; nonclinical and clinical mutually inclusive) and public availability of nonclinical and clinical performance data (available/not provided/not applicable). Results Between 1997 and 2016, the FDA cleared 377 moderate-risk otolaryngologic devices. The majority were therapeutic (n = 240/377 [63.7%]) and otologic (n = 311/377 [82.5%]); roughly one-third (n = 121/377 [32.1%]) were implantable. Few (n = 10/377 [2.7%]) devices were subject to recall. FDA documents summarizing premarket evidence were accessible for two-thirds (n = 247/377 [65.5%]) of devices. Among these devices, one-quarter (n = 66/247 [26.7%]) were supported by clinical evidence. The majority (n = 177/247 [71.7%]) were supported by nonclinical evidence, although nearly one-quarter (n = 58/247 [23.5%]) were cleared without supporting evidence. Therapeutic devices were more often cleared without supporting evidence (therapeutic: n = 53/170 [31.2%]; diagnostic: n = 5/77 [6.5%]; P < .0001). Nonclinical and clinical performance data were rarely available (nonclinical: n = 49/247 [19.8%]; clinical: n = 32/247 [13.0%]) within public summaries. Conclusion The FDA cleared most moderate-risk otolaryngologic devices for marketing via the 510(k) process without clinical evidence of safety and effectiveness. Otolaryngologists should

Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.

PubMed

1985-10-22

The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."

ESnet authentication services and trust federations

NASA Astrophysics Data System (ADS)

Muruganantham, Dhivakaran; Helm, Mike; Genovese, Tony

2005-01-01

ESnet provides authentication services and trust federation support for SciDAC projects, collaboratories, and other distributed computing applications. The ESnet ATF team operates the DOEGrids Certificate Authority, available to all DOE Office of Science programs, plus several custom CAs, including one for the National Fusion Collaboratory and one for NERSC. The secure hardware and software environment developed to support CAs is suitable for supporting additional custom authentication and authorization applications that your program might require. Seamless, secure interoperation across organizational and international boundaries is vital to collaborative science. We are fostering the development of international PKI federations by founding the TAGPMA, the American regional PMA, and the worldwide IGTF Policy Management Authority (PMA), as well as participating in European and Asian regional PMAs. We are investigating and prototyping distributed authentication technology that will allow us to support the "roaming scientist" (distributed wireless via eduroam), as well as more secure authentication methods (one-time password tokens).

Field-based performance of three pre-market rapid hepatitis C virus antibody assays in STAHR (Study to Assess Hepatitis C Risk) among young adults who inject drugs in San Diego, CA.

PubMed

Jewett, A; Smith, B D; Garfein, R S; Cuevas-Mota, J; Teshale, E H; Weinbaum, C M

2012-07-01

Approximately 4.1 million Americans are estimated to have been infected with hepatitis C virus (HCV), 45-85% of whom are unaware of their infection. Persons who inject drugs (PWID) account for 55.8% of all persons with HCV antibody (anti-HCV) in the U.S. PWID have limited access to healthcare and are infrequently tested for anti-HCV using conventional laboratory assays. To evaluate performance characteristics (sensitivity and specificity) of three, pre-market rapid point-of-care tests (one oral fluid and two finger-stick assays) from two manufacturers (Chembio and MedMira) in settings providing services to young adult PWID in San Diego, CA. Behavioral risk assessment surveys and testing for HCV were conducted among persons who reported injection drug use (IDU) within the past 6 months as part of the Study to Assess Hepatitis C Risk (STAHR) among PWID aged 18-40 years in 2009-2010. Sensitivity and specificity of the rapid anti-HCV assays were evaluated among STAHR participants, using two commonly used testing algorithms. Variability in sensitivity (76.6-97.1%) and specificity (99.0-100.0%) was found across assays. The highest sensitivity achieved for the Chembio finger-stick blood, Chembio oral fluid and MedMira finger-stick blood tests was 97.1%, 85.4% and 80.0% respectively; the highest specificity was 99.0%, 100.0% and 100.0%, respectively. In multivariate analysis false negative anti-HCV results were associated with female sex for the MedMira blood assay. Sensitive anti-HCV rapid assays are appropriate and feasible for high-prevalence, high-risk populations such as young PWID. Copyright © 2012 Elsevier B.V. All rights reserved.

The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

PubMed

Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

2018-04-20

A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

R3D: Reduction Package for Integral Field Spectroscopy

NASA Astrophysics Data System (ADS)

Sánchez, Sebastián. F.

2011-06-01

R3D was developed to reduce fiber-based integral field spectroscopy (IFS) data. The package comprises a set of command-line routines adapted for each of these steps, suitable for creating pipelines. The routines have been tested against simulations, and against real data from various integral field spectrographs (PMAS, PPAK, GMOS, VIMOS and INTEGRAL). Particular attention is paid to the treatment of cross-talk. R3D unifies the reduction techniques for the different IFS instruments to a single one, in order to allow the general public to reduce different instruments data in an homogeneus, consistent and simple way. Although still in its prototyping phase, it has been proved to be useful to reduce PMAS (both in the Larr and the PPAK modes), VIMOS and INTEGRAL data. The current version has been coded in Perl, using PDL, in order to speed-up the algorithm testing phase. Most of the time critical algorithms have been translated to C[float=][/float], and it is our intention to translate all of them. However, even in this phase R3D is fast enough to produce valuable science frames in reasonable time.

KSC-98pc646

NASA Image and Video Library

1998-05-22

KENNEDY SPACE CENTER, FLA. -- The International Space Station's (ISS) Unity node, with Pressurized Mating Adapter (PMA)-2 attached, awaits further processing by Boeing technicians in its workstand in the Space Station Processing Facility (SSPF). The Unity node is the first element of the ISS to be manufactured in the United States and is currently scheduled to lift off aboard the Space Shuttle Endeavour on STS-88 later this year. Unity has two PMAs attached to it now that this mate is completed. PMAs are conical docking adapters which will allow the docking systems used by the Space Shuttle and by Russian modules to attach to the node's hatches and berthing mechanisms. Once in orbit, Unity, which has six hatches, will be mated with the already orbiting Control Module and will eventually provide attachment points for the U.S. laboratory module; Node 3; an early exterior framework or truss for the station; an airlock; and a multi-windowed cupola. The Control Module, or Functional Cargo Block, is a U.S.-funded and Russian-built component that will be launched aboard a Russian rocket from Kazakstan

Post-Stroke Longitudinal Alterations of Inter-Hemispheric Correlation and Hemispheric Dominance in Mouse Pre-Motor Cortex

PubMed Central

Panarese, Alessandro; Alia, Claudia; Micera, Silvestro; Caleo, Matteo; Di Garbo, Angelo

2016-01-01

Purpose Limited restoration of function is known to occur spontaneously after an ischemic injury to the primary motor cortex. Evidence suggests that Pre-Motor Areas (PMAs) may “take over” control of the disrupted functions. However, little is known about functional reorganizations in PMAs. Forelimb movements in mice can be driven by two cortical regions, Caudal and Rostral Forelimb Areas (CFA and RFA), generally accepted as primary motor and pre-motor cortex, respectively. Here, we examined longitudinal changes in functional coupling between the two RFAs following unilateral photothrombotic stroke in CFA (mm from Bregma: +0.5 anterior, +1.25 lateral). Methods Local field potentials (LFPs) were recorded from the RFAs of both hemispheres in freely moving injured and naïve mice. Neural signals were acquired at 9, 16 and 23 days after surgery (sub-acute period in stroke animals) through one bipolar electrode per hemisphere placed in the center of RFA, with a ground screw over the occipital bone. LFPs were pre-processed through an efficient method of artifact removal and analysed through: spectral,cross-correlation, mutual information and Granger causality analysis. Results Spectral analysis demonstrated an early decrease (day 9) in the alpha band power in both the RFAs. In the late sub-acute period (days 16 and 23), inter-hemispheric functional coupling was reduced in ischemic animals, as shown by a decrease in the cross-correlation and mutual information measures. Within the gamma and delta bands, correlation measures were already reduced at day 9. Granger analysis, used as a measure of the symmetry of the inter-hemispheric causal connectivity, showed a less balanced activity in the two RFAs after stroke, with more frequent oscillations of hemispheric dominance. Conclusions These results indicate robust electrophysiological changes in PMAs after stroke. Specifically, we found alterations in transcallosal connectivity, with reduced inter-hemispheric functional

Post-Stroke Longitudinal Alterations of Inter-Hemispheric Correlation and Hemispheric Dominance in Mouse Pre-Motor Cortex.

PubMed

Vallone, Fabio; Lai, Stefano; Spalletti, Cristina; Panarese, Alessandro; Alia, Claudia; Micera, Silvestro; Caleo, Matteo; Di Garbo, Angelo

2016-01-01

Limited restoration of function is known to occur spontaneously after an ischemic injury to the primary motor cortex. Evidence suggests that Pre-Motor Areas (PMAs) may "take over" control of the disrupted functions. However, little is known about functional reorganizations in PMAs. Forelimb movements in mice can be driven by two cortical regions, Caudal and Rostral Forelimb Areas (CFA and RFA), generally accepted as primary motor and pre-motor cortex, respectively. Here, we examined longitudinal changes in functional coupling between the two RFAs following unilateral photothrombotic stroke in CFA (mm from Bregma: +0.5 anterior, +1.25 lateral). Local field potentials (LFPs) were recorded from the RFAs of both hemispheres in freely moving injured and naïve mice. Neural signals were acquired at 9, 16 and 23 days after surgery (sub-acute period in stroke animals) through one bipolar electrode per hemisphere placed in the center of RFA, with a ground screw over the occipital bone. LFPs were pre-processed through an efficient method of artifact removal and analysed through: spectral,cross-correlation, mutual information and Granger causality analysis. Spectral analysis demonstrated an early decrease (day 9) in the alpha band power in both the RFAs. In the late sub-acute period (days 16 and 23), inter-hemispheric functional coupling was reduced in ischemic animals, as shown by a decrease in the cross-correlation and mutual information measures. Within the gamma and delta bands, correlation measures were already reduced at day 9. Granger analysis, used as a measure of the symmetry of the inter-hemispheric causal connectivity, showed a less balanced activity in the two RFAs after stroke, with more frequent oscillations of hemispheric dominance. These results indicate robust electrophysiological changes in PMAs after stroke. Specifically, we found alterations in transcallosal connectivity, with reduced inter-hemispheric functional coupling and a fluctuating dominance

Retrograde open mesenteric stenting for acute mesenteric ischemia.

PubMed

Blauw, Juliette T M; Meerwaldt, Robert; Brusse-Keizer, Marjolein; Kolkman, Jeroen J; Gerrits, Dick; Geelkerken, Robert H

2014-09-01

Acute mesenteric ischemia (AMI) encompasses the sequels of end-stage untreated chronic mesenteric ischemia and acute mesenteric artery thrombosis. Percutaneous mesenteric artery stenting (PMAS) is the preferred treatment of patients with AMI but is not always feasible. Retrograde open mesenteric stenting (ROMS) is a hybrid technique that combines the advantages of open surgical and endovascular approaches. The literature on the results of this new technique is scarce. The aim of this study was to evaluate the results of ROMS in a consecutive series of patients with AMI. All patients with emergent mesenteric revascularization for AMI between January 2007 and September 2011 were entered in our prospective registry. Technical success, mortality, patency, clinical success, and complication rate at 30 days and 6 and 12 months were assessed. Sixty-eight patients presented with AMI and 54 underwent PMAS, of which four were unsuccessful and followed by ROMS. Eleven patients were directly treated with ROMS, making a total of 15 patients (10 women and five men; median age, 66 years [interquartile range, 54-73 years]). In all patients, only the superior mesenteric artery was revascularized. In nine of the 15 patients, all three mesenteric arteries were severely stenotic or occluded. Technical success was achieved in 14 patients. At ROMS in two patients, the small bowel was severely ischemic. One of these patients needed a partial bowel resection because of irreversible transmural ischemia. At 30 days, the mortality rate was 20% and the primary patency was 92%. Ten patients underwent unplanned relaparotomy, of whom one needed resection of a large part of the small bowel. At 12 months, the mortality rate was still 20%. The primary patency was 83%. Primary assisted patency was 91%, and secondary patency was 100%. Clinical success at 30 days, 6 months, and 12 months, respectively, was 73%, 67%, and 67%. AMI is still a devastating event. If PMAS is not feasible, ROMS is a reliable

The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

PubMed

Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

2018-05-04

Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional

An overview of the regulatory aspects of medical devices from the viewpoint of research and device manufacturing.

PubMed

Patrick, J

1993-01-01

To review the Food and Drug Administration's regulatory requirements for bringing a new or substantially changed medical device to market in the United States, noting the history and current requirements for the continuous spinal catheter. The relevant laws and guidelines for classifying, testing, and submitting a device to Food and Drug Administration approval are reviewed. The Food and Drug Administration categorizes medical devices into three classes, based on potential risk for illness or injury presented by a malfunction or failure. Class III devices are the most critical ones, and require a Premarket Approval that includes clinical trials before market introduction. Classes I and II usually require a 510(k), or premarket notification, which usually does not need any clinical data. Testing requirements include biocompatibility testing; physical, functional, and packaging testing; and sterility testing. The continuous spinal catheter (25-32 gauge) was marketed under a 510(k) claiming substantial equivalence to the Bizzarri-Giuffrida 24-gauge catheter, which was a pre-Amendment device. After incidences of cauda equina syndrome were reported with use of the continuous spinal technique, the Food and Drug Administration reclassified the small-gauge catheters as Class III devices, which require a Premarket Approval before being marketed.

Creation of an iOS and Android Mobile Application for Inferior Vena Cava (IVC) Filters: A Powerful Tool to Optimize Care of Patients with IVC Filters

PubMed Central

Deso, Steven E.; Idakoji, Ibrahim A.; Muelly, Michael C.; Kuo, William T.

2016-01-01

Owing to a myriad of inferior vena cava (IVC) filter types and their potential complications, rapid and correct identification may be challenging when encountered on routine imaging. The authors aimed to develop an interactive mobile application that allows recognition of all IVC filters and related complications, to optimize the care of patients with indwelling IVC filters. The FDA Premarket Notification Database was queried from 1980 to 2014 to identify all IVC filter types in the United States. An electronic search was then performed on MEDLINE and the FDA MAUDE database to identify all reported complications associated with each device. High-resolution photos were taken of each filter type and corresponding computed tomographic and fluoroscopic images were obtained from an institutional review board–approved IVC filter registry. A wireframe and storyboard were created, and software was developed using HTML5/CSS compliant code. The software was deployed using PhoneGap (Adobe, San Jose, CA), and the prototype was tested and refined. Twenty-three IVC filter types were identified for inclusion. Safety data from FDA MAUDE and 72 relevant peer-reviewed studies were acquired, and complication rates for each filter type were highlighted in the application. Digital photos, fluoroscopic images, and CT DICOM files were seamlessly incorporated. All data were succinctly organized electronically, and the software was successfully deployed into Android (Google, Mountain View, CA) and iOS (Apple, Cupertino, CA) platforms. A powerful electronic mobile application was successfully created to allow rapid identification of all IVC filter types and related complications. This application may be used to optimize the care of patients with IVC filters. PMID:27247483

Creation of an iOS and Android Mobile Application for Inferior Vena Cava (IVC) Filters: A Powerful Tool to Optimize Care of Patients with IVC Filters.

PubMed

Deso, Steven E; Idakoji, Ibrahim A; Muelly, Michael C; Kuo, William T

2016-06-01

Owing to a myriad of inferior vena cava (IVC) filter types and their potential complications, rapid and correct identification may be challenging when encountered on routine imaging. The authors aimed to develop an interactive mobile application that allows recognition of all IVC filters and related complications, to optimize the care of patients with indwelling IVC filters. The FDA Premarket Notification Database was queried from 1980 to 2014 to identify all IVC filter types in the United States. An electronic search was then performed on MEDLINE and the FDA MAUDE database to identify all reported complications associated with each device. High-resolution photos were taken of each filter type and corresponding computed tomographic and fluoroscopic images were obtained from an institutional review board-approved IVC filter registry. A wireframe and storyboard were created, and software was developed using HTML5/CSS compliant code. The software was deployed using PhoneGap (Adobe, San Jose, CA), and the prototype was tested and refined. Twenty-three IVC filter types were identified for inclusion. Safety data from FDA MAUDE and 72 relevant peer-reviewed studies were acquired, and complication rates for each filter type were highlighted in the application. Digital photos, fluoroscopic images, and CT DICOM files were seamlessly incorporated. All data were succinctly organized electronically, and the software was successfully deployed into Android (Google, Mountain View, CA) and iOS (Apple, Cupertino, CA) platforms. A powerful electronic mobile application was successfully created to allow rapid identification of all IVC filter types and related complications. This application may be used to optimize the care of patients with IVC filters.

Regulatory issues relating to therapies for periodontal regeneration.

PubMed

Singleton, D G; Torres-Cabassa, A

1997-03-01

The Food and Drug Administration (FDA) has regulated medical devices since May 1976, when the Medical Device Amendments were enacted. The clinical trial requirements for the marketing of periodontal regeneration devices have been dependent, in part, on the degree of their similarity to devices marketed prior to the legislative enactment date in terms of materials, indication statements, and labeling claims. Nonresorbable barriers were allowed to be marketed based on their equivalence to devices marketed prior to the enactment date based on biocompatability and clinical trial data under the premarket notification requirements section of the law. Bone filling materials such as hydroxyapatite were first marketed based on the finding of equivalence to predicate devices. Newer technologies such as bioabsorbable barriers have also been reviewed under the premarket notification provisions of the law, but manufacturers have been required to provide more extensive safety and effectiveness data to establish equivalence to pre-Amendments devices. Data to answer questions related to the potential toxicity of breakdown products, period of absorption, and ultimate clinical effectiveness needed to be answered prior to marketing. New devices that incorporate technologies that are not substantially equivalent to predicate devices must proceed through the premarket approval route to marketing. For new devices considered a potential significant risk to the patient population, clinical trials are conducted via the investigational device exemption (IDE) requirements that specify the means by which trials will proceed in order to protect the rights of patients. New devices of organic origin, such as bone morphogenic protein, have followed the premarket approval route with IDE requirements instituted as a condition for their path to the marketplace. Issues associated with immediate and long-term contact including potential toxicity, tumorigenicity, and sensitization need to be addressed

Establishing a system with Drosophila melanogaster (Diptera: Drosophilidae) to assess the non-target effects of gut-active insecticidal compounds.

PubMed

Haller, Simone; Meissle, Michael; Romeis, Jörg

2016-12-01

Potentially adverse effects on ecosystem functioning by the planting of insect-resistant, genetically engineered plants or by the direct application of insecticidal compounds are carefully evaluated in pre-market risk assessments. To date, few studies have assessed the potential risks of genetically engineered crops or insecticidal compounds on the survival and fitness of dipteran species, despite their important contribution to ecosystem services such as decomposition in agricultural systems. Therefore, we propose that Drosophila melanogaster Meigen (Drosophilidae) be used as a surrogate species for the order Diptera and for the functional guild of soil arthropod decomposers in pre-market risk assessments. We developed two assays to assess the toxicity of gut-active insecticidal compounds to D. melanogaster. One assay uses groups of fly larvae, and the other uses individuals. Cryolite, a mineral pesticide, proved to be an adequate positive control. The effects of cryolite on D. melanogaster larvae were comparable between the two assays. Statistical power analyses were used to define the number of replications required to identify different effect sizes between control and treatment groups. Finally, avidin, E-64, GNA, and SBTI were used as test compounds to validate the individual-based assay; only avidin adversely affected D. melanogaster. These results indicate that both D. melanogaster assays will be useful for early tier risk assessment concerning the effects of orally active compounds on non-target dipterans.

Improving the postmarket surveillance of total joint arthroplasty devices.

PubMed

Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B; Brennan, Troyen A; Liang, Matthew H

2008-01-01

To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.

JOURNAL CLUB: The Warthin Tumor Score: A Simple and Reliable Method to Distinguish Warthin Tumors From Pleomorphic Adenomas and Carcinomas.

PubMed

Wang, Chih-Wei; Chu, Yueng-Hsiang; Chiu, Deng-Yiv; Shin, Nieh; Hsu, Hsian-He; Lee, Jih-Chin; Juan, Chun-Jung

2018-06-01

The objective of this article is to propose a Warthin tumor (WT) score to distinguish WTs from other parotid tumors. The study included 78 patients with 92 histologically proven parotid tumors, including 42 WTs, 30 pleomorphic adenomas (PMAs), and 20 carcinomas. Echo-planar DW images were acquired. The WT score, which comprised the mean apparent diffusion coefficient (ADC M ) and the SD of the ADC (ADC SD ) of tumors, patient age, and patient sex, was used to predict WTs. The diagnostic performance of the WT score was evaluated using ROC analyses. Statistical significance was denoted by p < 0.05. With the use of optimized criteria, including an ADC M less than or equal to 1.016 × 10 -3 mm 2 /s (WT score, 1), an ADC SD less than or equal to 0.1171 × 10 -3 mm 2 /s (WT score, 1), patient age older than 49 years (WT score, 1), and male sex (WT score, 1), a WT score greater than 2 had a sensitivity, specificity, positive negative value, negative predictive value, and accuracy of 85.7%, 100.0%, 100.0%, 89.3%, and 93.4%, respectively. The WT score allows parotid WTs to be distinguished from PMAs and carcinomas with high accuracy.

Employment status among parenting teenage mothers enrolled in high school.

PubMed

Smith, Matthew Lee; Wilson, Kelly L

2014-09-01

Many programs emphasize subsequent pregnancy prevention and high school graduation among teenage mothers; however, less is known about their ability to increase financial earnings from employment opportunities while concurrently enrolled in school. This study evaluates factors influencing employment status among teenage mothers after enrolling in a community-based randomized intervention. Project Mothers and Schools (PMAS) initiative participants were surveyed at baseline and 12 months after enrollment. The 56 control group participants received homebound education and family case management, whereas the 59 intervention group participants received these basic-level services as well as group parenting time, life skills, and leadership training. A generalized estimating equation was used to identify statistically significant changes associated with the intervention. Participants were significantly more likely to receive money from their jobs at postintervention relative to baseline (OR = 4.75, p = .023); however, this change was not statistically significant when comparing the control group to the intervention group. At postintervention, those who received money from parents were significantly less likely to receive money from their job (OR = 0.12, p = .002). While PMAS benefited participants in terms of employment, the role of parental support requires additional investigation to determine its influence on teenage mothers' ability to achieve financial independence. © 2014, American School Health Association.

Estimating the Effects of Climate Change on Federal Hydropower and Power Marketing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sale, Michael J; Kao, Shih-Chieh; Uria Martinez, Rocio

The U.S. Department of Energy is currently preparing an assessment of the effects of climate change on federal hydropower, as directed by Congress in Section 9505 of the Secure Water Act of 2009 (P.L. 111-11). This paper describes the assessment approach being used in a Report to Congress currently being prepared by Oak Ridge National Laboratory. The 9505 assessment will examine climate change effects on water available for hydropower operations and the future power supplies marketed from federal hydropower projects. It will also include recommendations from the Power Marketing Administrations (PMAs) on potential changes in operation or contracting practices thatmore » could address these effects and risks of climate change. Potential adaption and mitigation strategies will also be identified. Federal hydropower comprises approximately half of the U.S. hydropower portfolio. The results from the 9505 assessment will promote better understanding among federal dam owners/operators of the sensitivity of their facilities to water availability, and it will provide a basis for planning future actions that will enable adaptation to climate variability and change. The end-users of information are Congressional members, their staff, the PMAs and their customers, federal dam owners/operators, and the DOE Water Power Program.« less

Hierarchical Compliance Control of a Soft Ankle Rehabilitation Robot Actuated by Pneumatic Muscles.

PubMed

Liu, Quan; Liu, Aiming; Meng, Wei; Ai, Qingsong; Xie, Sheng Q

2017-01-01

Traditional compliance control of a rehabilitation robot is implemented in task space by using impedance or admittance control algorithms. The soft robot actuated by pneumatic muscle actuators (PMAs) is becoming prominent for patients as it enables the compliance being adjusted in each active link, which, however, has not been reported in the literature. This paper proposes a new compliance control method of a soft ankle rehabilitation robot that is driven by four PMAs configured in parallel to enable three degrees of freedom movement of the ankle joint. A new hierarchical compliance control structure, including a low-level compliance adjustment controller in joint space and a high-level admittance controller in task space, is designed. An adaptive compliance control paradigm is further developed by taking into account patient's active contribution and movement ability during a previous period of time, in order to provide robot assistance only when it is necessarily required. Experiments on healthy and impaired human subjects were conducted to verify the adaptive hierarchical compliance control scheme. The results show that the robot hierarchical compliance can be online adjusted according to the participant's assessment. The robot reduces its assistance output when participants contribute more and vice versa , thus providing a potentially feasible solution to the patient-in-loop cooperative training strategy.

Hierarchical Compliance Control of a Soft Ankle Rehabilitation Robot Actuated by Pneumatic Muscles

PubMed Central

Liu, Quan; Liu, Aiming; Meng, Wei; Ai, Qingsong; Xie, Sheng Q.

2017-01-01

Traditional compliance control of a rehabilitation robot is implemented in task space by using impedance or admittance control algorithms. The soft robot actuated by pneumatic muscle actuators (PMAs) is becoming prominent for patients as it enables the compliance being adjusted in each active link, which, however, has not been reported in the literature. This paper proposes a new compliance control method of a soft ankle rehabilitation robot that is driven by four PMAs configured in parallel to enable three degrees of freedom movement of the ankle joint. A new hierarchical compliance control structure, including a low-level compliance adjustment controller in joint space and a high-level admittance controller in task space, is designed. An adaptive compliance control paradigm is further developed by taking into account patient’s active contribution and movement ability during a previous period of time, in order to provide robot assistance only when it is necessarily required. Experiments on healthy and impaired human subjects were conducted to verify the adaptive hierarchical compliance control scheme. The results show that the robot hierarchical compliance can be online adjusted according to the participant’s assessment. The robot reduces its assistance output when participants contribute more and vice versa, thus providing a potentially feasible solution to the patient-in-loop cooperative training strategy. PMID:29255412

21 CFR 862.1500 - Malic dehydrogenase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket...

77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-13

.... Docket No. Applicant Trade name Approval date P100031, FDA-2011-M-0502...... Roche Diagnostics ELECSYS......... Roche Diagnostics ELECSYS ANTI-HBC IMMUNOASSAY, June 27, 2011. Corp.. ELECSYS PRECICONTROL ANTI-HBC FOR... IMMUNODIAGNOSTICS July 20, 2011. Diagnostics, PRODUCTS ANTI-HBE REAGENT PACK, Inc.. VITROS IMMUNODIAGNOSTIC PRODUCTS...

21 CFR 862.1660 - Quality control material (assayed and unassayed).

Code of Federal Regulations, 2010 CFR

2010-04-01

... includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds...). Except when used in donor screening tests, unassayed material is exempt from the premarket notification...

21 CFR 862.1560 - Urinary phenylketones (nonquantitative) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 862.1380 - Hydroxybutyric dehydrogenase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1470 - Lipid (total) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 862.1805 - Vitamin A test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-23

... provides industry and agency staff with updated recommendations concerning 510(k) submissions for various... will be relevant for premarket notification (510(k)) submissions for these device types. Detection...

Metrological Reliability of Medical Devices

NASA Astrophysics Data System (ADS)

Costa Monteiro, E.; Leon, L. F.

2015-02-01

The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

21 CFR 862.1605 - Pregnanediol test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 874.1800 - Air or water caloric stimulator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... vestibular function testing of a patient's body balance system. The vestibular stimulation of the...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

... Tobacco Control Act amends the FD&C Act and grants FDA authority to regulate the manufacture, marketing... (PMTA) under section 910(b) of the FD&C Act and receive a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act prior to marketing the product. The draft guidance is intended to...

21 CFR 862.1590 - Porphobilinogen test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1790 - Uroporphyrin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1595 - Porphyrins test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1620 - Progesterone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

Hematology and pathology devices; reclassification of the automated differential cell counter. Final rule.

PubMed

2002-01-14

The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.

21 CFR 864.3300 - Cytocentrifuge.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 864.3300 - Cytocentrifuge.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 874.4100 - Epistaxis balloon.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

Safety Network to Detect Performance Degradation and Pilot Incapacitation (Reseau de securite pour detecter la degradation des performances et la defaillance du pilote)

DTIC Science & Technology

1990-09-01

military pilot acceptance of a safety network system would be based , as always, on the following: a. Do I really need such a system and will it be a...inferring pilot state based on computer analysis of pilot control inputs (or lack of)l. Having decided that the pilot is incapacitated, PMAS would alert...the advances being made in neural network computing machinery have necessitated a complete re-thinking of the conventional serial von Neuman machine

21 CFR 880.5475 - Jet lavage.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

21 CFR 880.5475 - Jet lavage.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

21 CFR 886.3800 - Scleral shell.

Code of Federal Regulations, 2012 CFR

2012-04-01

... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 886.3800 - Scleral shell.

Code of Federal Regulations, 2014 CFR

2014-04-01

... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 886.3800 - Scleral shell.

Code of Federal Regulations, 2013 CFR

2013-04-01

... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 872.3220 - Facebow.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for use in denture fabrication to determine the spatial relationship between the upper and lower jaws.... Class I (general controls). The device is exempt from the premarket notification procedures in subpart E...

TU-AB-204-03: Research Activities in Medical Physics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Badano, A.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

TU-AB-204-01: Device Approval Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Delfino, J.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

TU-AB-204-02: Device Adverse Events and Compliance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gonzales, S.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

TU-AB-204-04: Partnerships

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ochs, R.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

21 CFR 868.1575 - Gas collection vessel.

Code of Federal Regulations, 2012 CFR

2012-04-01

... for subsequent analysis. It does not include a sampling pump. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 876.5160 - Urological clamp for males.

Code of Federal Regulations, 2010 CFR

2010-04-01

... temporarily. It is an external clamp. (b) Classification. Class I (general controls). Except when intended for internal use or use on females, the device is exempt from the premarket notification procedures in subpart...

21 CFR 862.1130 - Blood volume test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte... the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. [52...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2013 CFR

2013-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2011 CFR

2011-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2014 CFR

2014-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

21 CFR 886.4070 - Powered corneal burr.

Code of Federal Regulations, 2012 CFR

2012-04-01

... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

[Companion diagnostics "POTELIGEO TEST IHC/FCM" used with "POTELIGEO" (mogamulizumab) for adult T-cell leukemia-lymphoma (ATL) treatment].

PubMed

Goami, Takeshi

2014-05-01

Personalized medicine offers the best treatment for individual patients, it is important for an IVD manufacturer to develop companion diagnostics in parallel with the development of new drugs through close cooperation with drug companies, and supply diagnostics companies with new drugs for physicians and patients. We received approval for a premarket approval application (PMA) for two in vitro diagnostic ("IVD") reagents, POTELIGEO TEST IHC and POTELIGEO TEST FCM ("POTELIGEO TEST"), in March 2012, and subsequently launched POTELIGEO TEST in May 2012. POTELIGEO TEST is a companion diagnostic used with POTELIGEO for which Kyowa Hakko Kirin has a new drug application (NDA) that was approved in March 2012, and is designed to help physicians identify appropriate subpopulations of adult T-cell leukemia-lymphoma(ATL) patients who are most likely to respond to POTELIGEO 20 mg (mogamulizumab) Injection ("POTELIGEO").

21 CFR 872.3730 - Pantograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... and, as the patient's mouth opens, the pen records on graph paper the angle between the upper and the lower jaw. (b) Classification. Class I (general controls). The device is exempt from the premarket...

21 CFR 870.5225 - External counter-pulsating device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b) Classification. Class III (premarket approval). (c) Date PMA...

21 CFR 876.4480 - Electrohydraulic lithotriptor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode... special control for this device is FDA's “Guidance for the Content of Premarket Notifications for...

21 CFR 876.4480 - Electrohydraulic lithotriptor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode... special control for this device is FDA's “Guidance for the Content of Premarket Notifications for...

21 CFR 870.5225 - External counter-pulsating device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b) Classification. Class III (premarket approval). (c) Date PMA...

21 CFR 870.5225 - External counter-pulsating device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b) Classification. Class III (premarket approval). (c) Date PMA...

21 CFR 870.5225 - External counter-pulsating device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b) Classification. Class III (premarket approval). (c) Date PMA...

Is it all worth it? The experiences of new PhDs on the job market, 2007-10.

PubMed

McFall, Brooke Helppie; Murray-Close, Marta; Willis, Robert J; Chen, Uniko

This paper describes the job market experiences of new PhD economists, 2007-10. Using information from PhD programs' job candidate websites and original surveys, the authors present information about job candidates' characteristics, preferences and expectations; how job candidates fared at each stage of the market; and predictors of outcomes at each stage. Some information presented in this paper updates findings of prior studies. However, design features of the data used in this paper may result in more generalizable findings. This paper is unique in comparing pre-market expectations and preferences with post-market outcomes on the new PhD job market. It shows that outcomes tend to align with pre-market preferences, and candidates' expectations are somewhat predictive of their outcomes. Several analyses also shed light on sub-group differences.

Is it all worth it? The experiences of new PhDs on the job market, 2007–10

PubMed Central

McFall, Brooke Helppie; Murray-Close, Marta; Willis, Robert J; Chen, Uniko

2016-01-01

This paper describes the job market experiences of new PhD economists, 2007-10. Using information from PhD programs' job candidate websites and original surveys, the authors present information about job candidates' characteristics, preferences and expectations; how job candidates fared at each stage of the market; and predictors of outcomes at each stage. Some information presented in this paper updates findings of prior studies. However, design features of the data used in this paper may result in more generalizable findings. This paper is unique in comparing pre-market expectations and preferences with post-market outcomes on the new PhD job market. It shows that outcomes tend to align with pre-market preferences, and candidates' expectations are somewhat predictive of their outcomes. Several analyses also shed light on sub-group differences. PMID:27616783

21 CFR 888.4800 - Template for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cutting. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. [52 FR...

21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

Code of Federal Regulations, 2011 CFR

2011-04-01

... defined in § 20.81. (2) Any protocol for a test or study unless the protocol is shown to constitute trade... available for public disclosure. (3) Quantitative or semiquantitative formulas. [51 FR 26364, July 22, 1986...

Effects of Climate Change on Federal Hydropower. Report to Congress

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

This is a formal Department of Energy report to Congress. It outlines the findings of an assessment directed by Congress in Section 9505 of the SECURE Water Act of 2009 (Public Law 111-11), the US Department of Energy (DOE), in consultation with the federal Power Marketing Administrations (PMAs) and other federal agencies, including federal dam owners, has prepared a comprehensive assessment examining the effects of climate change on water available for hydropower at federal facilities and on the marketing of power from these federal facilities.

76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related... ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement...

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

77 FR 75173 - Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... performing the technical analysis, management assessment, and program evaluation tasks required to address... premarket reviews that meet regulatory review standards. 2. Analysis of elements of the review process... process. This includes analysis of root causes for inefficiencies that may affect review performance and...

Gastroenterology-urology devices; reclassification of implanted blood access devices. Final rule.

PubMed

2014-07-25

The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.

Minimum Risk Pesticide: Definition and Product Confirmation

EPA Pesticide Factsheets

Minimum risk pesticides pose little to no risk to human health or the environment and therefore are not subject to regulation under FIFRA. EPA does not do any pre-market review for such products or labels, but violative products are subject to enforcement.

78 FR 45538 - The Patient Preference Initiative: Incorporating Patient Preference Information Into the Medical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-29

... decision making. It also aims to advance the science of measuring treatment preferences of patients...: Incorporating Patient Preference Information into the Medical Device Regulatory Processes.'' The purpose of the... predictability, consistency, and transparency of the premarket review process. In 2012, CDRH published the...

75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...

78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... assessment. In some cases, a PMA may include multiple studies designed to answer different scientific... designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles...

New orthopedic devices and the FDA.

PubMed

Sheth, Ujash; Nguyen, Nhu-An; Gaines, Sean; Bhandari, Mohit; Mehlman, Charles T; Klein, Guy

2009-01-01

Each year the field of orthopedics is introduced to an influx of new medical devices. Each of these medical devices has faced certain hurdles prior to being approved for marketing by the U.S. Food and Drug Administration (FDA). Among the regulatory pathways available, the 510(k) premarket notification is by far the one most commonly used. The 510(k) premarket notification allows the manufacturer to receive prompt approval of their device by demonstrating that it is "substantially equivalent" to an existing legally marketed device. In most instances, this proof of substantial equivalence allows manufacturers of medical devices to bypass the use of clinical trials, which are a hallmark of the approval process for new drugs. As a result, most medical devices are approved without demonstrating safety or effectiveness. This article reviews the regulatory processes used by the FDA to evaluate new orthopedic devices.

Safety monitoring of ophthalmic biologics: a systematic review of pre- and postmarketing safety data.

PubMed

Penedones, Ana; Mendes, Diogo; Alves, Carlos; Batel Marques, Francisco

2014-11-01

The present study evaluates the safety of the biologics approved for the treatment of ocular diseases. The European medicines agency Website was searched to identify biologics with approved ophthalmologic therapeutic indications. A systematic search was performed using MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) and the International Clinical Trials Registry Platform up to December 2013. Pre-marketing, phase III randomized controlled trials (RCT), postmarketing clinical trials, observational longitudinal studies, and case reports involving adverse events (AE) were included. Methodological quality was assessed by Downs & Black checklist. All European spontaneous reports of AE included in the Eudravigilance up to December 2013 were also considered. AE were classified as ocular (related and non-related with the injection procedure) and non-ocular (related or non-related with vascular endothelial growth factor inhibition). Incidences of all reported AEs were estimated. Pegaptanib, ranibizumab, and aflibercept were identified as ophthalmic biologics. Fourteen premarketing RCT, 7 postmarketing clinical trials, 31 observational studies, along with 31 case reports and 7,720 spontaneous reports were identified and included in this study. Both in pre- and postmarketing settings, ocular AEs were more frequent than non-ocular AEs. Premarketing safety data inform the most common AEs. Postmarketing studies suggest an increased number of events such as retinal pigmented epithelium tears (0.6%-24%), thromboembolic events (0.8%-5%), and mortality (2.8%-4%). This study highlights the need to properly evaluate the risk for rare, serious, and long-term AEs, such as thromboembolic events, since they can lead to imbalances in the benefit-risk ratio of biologics in ophthalmology.

77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... current knowledge about the safety and effectiveness of the Wingspan Stent System with Gateway PTA Balloon... premarket and postmarket data. The Wingspan Stent System with Gateway PTA Balloon Catheter is a neurovascular stent, balloon catheter, and delivery system consisting of the following components: 1. Wingspan...

21 CFR 26.32 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... bodies (CAB's) assessed to be equivalent: (1) Under the U.S. system, surveillance/postmarket and initial/preapproval inspection reports; (2) Under the U.S. system, premarket (510(k)) product evaluation reports; (3...

76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk... versus its probable risk. This draft guidance sets out the factors FDA considers when making this... factors to consider when making benefit-risk determinations in medical device premarket review. It does...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 862.1365 - Glutathione test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

21 CFR 862.1365 - Glutathione test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

21 CFR 862.1365 - Glutathione test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

21 CFR 864.6600 - Osmotic fragility test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

Is It Really FDA Approved?

MedlinePlus

... has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Devices that present a low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and ...

76 FR 51986 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0410... Request; Premarket Notification for a New Dietary Ingredient AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

78 FR 36698 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three...

Guidance for Industry: Preparation of Premarket Submissions ...

Center for Food Safety and Applied Nutrition (CFSAN)

... 情况下，只需提供一个红外线（IR）光谱既可；但是在另外一些情况下，提供其他 信息则更为有用，例如可见光或紫外线吸收光谱或核磁共振（NMR）光谱。 ...

75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 [Docket No... Intended to Treat, Diagnose, or Cure AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend the regulations on premarket...

77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

... clinical investigations in determining the amounts and types of safety data to collect in trials conducted... types of safety data that should be collected during late-stage premarket and postmarket clinical...] Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late Stage...

21 CFR 807.25 - Information required for device establishment registration and device listing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

21 CFR 807.25 - Information required for device establishment registration and device listing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...

21 CFR 866.5735 - Prothrombin immunological test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-12

... regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and... devices that have established safety and effectiveness profiles and for which it believes 510(k) review is... 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the...

21 CFR 814.100 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use Devices § 814.100 Purpose and scope. (a... consistent with the protection of the public health and safety and with ethical standards, to encourage the...

21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

21 CFR 862.1650 - Pyruvate kinase test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

Patient safety and efficacy as measured by clinical trials and regulatory policy.

PubMed

Harvey, B E; Alpert, S

1997-01-01

Virtual Reality and other technological innovations in medicine provide new challenges to the regulatory framework of the premarket review process for medical devices. By reinventing the government-academia-industry partnership, clinical trial data necessary for a medical device to enter the market can be more efficiently obtained.

76 FR 15321 - SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-P-0176... of FDA's Denial of Premarket Approval AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that it intends to refer for review before...

78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to... controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval...

16 CFR 1633.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... confirmation test on the mattress set it manufactures. (r) Confirmation test means a pre-market test conducted... included; examples are convertible sofa bed mattresses, corner group mattresses, day bed mattresses, roll...) This term includes any one, or any combination of the following: replacing the ticking or batting...

16 CFR 1633.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... confirmation test on the mattress set it manufactures. (r) Confirmation test means a pre-market test conducted... included; examples are convertible sofa bed mattresses, corner group mattresses, day bed mattresses, roll...) This term includes any one, or any combination of the following: replacing the ticking or batting...

16 CFR 1633.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... confirmation test on the mattress set it manufactures. (r) Confirmation test means a pre-market test conducted... included; examples are convertible sofa bed mattresses, corner group mattresses, day bed mattresses, roll...) This term includes any one, or any combination of the following: replacing the ticking or batting...

16 CFR 1633.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... confirmation test on the mattress set it manufactures. (r) Confirmation test means a pre-market test conducted... included; examples are convertible sofa bed mattresses, corner group mattresses, day bed mattresses, roll...) This term includes any one, or any combination of the following: replacing the ticking or batting...

16 CFR § 1633.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... confirmation test on the mattress set it manufactures. (r) Confirmation test means a pre-market test conducted... included; examples are convertible sofa bed mattresses, corner group mattresses, day bed mattresses, roll...) This term includes any one, or any combination of the following: replacing the ticking or batting...

21 CFR 170.106 - Notification for a food contact substance formulation (NFCSF).

Code of Federal Regulations, 2013 CFR

2013-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket... and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Notification for a food contact substance...

21 CFR 170.106 - Notification for a food contact substance formulation (NFCSF).

Code of Federal Regulations, 2012 CFR

2012-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket... and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Notification for a food contact substance...

21 CFR 170.106 - Notification for a food contact substance formulation (NFCSF).

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket... and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Notification for a food contact substance...

21 CFR 170.106 - Notification for a food contact substance formulation (NFCSF).

Code of Federal Regulations, 2010 CFR

2010-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket... and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Notification for a food contact substance...

76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... medical device for its intended use. Evidence from one or more pivotal clinical studies generally serves... some cases, a PMA may include multiple studies designed to answer different scientific questions. The... studies intended to support premarket submissions for medical devices and for FDA staff who review those...

21 CFR 807.95 - Confidentiality of information.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: (1) Where the device is on the market, i.e., introduced or delivered for introduction into interstate commerce for commercial distribution; (2) Where the person submitting the premarket notification submission has disclosed, through advertising or any other manner, his intent to market the device to scientists...

Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.

PubMed

Steinvil, Arie; Rogers, Toby; Torguson, Rebecca; Waksman, Ron

2016-09-12

This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial. Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016. The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor. Following panel discussions and the evidence presented, the panel voted for approval of the device. Copyright © 2016 American College of Cardiology Foundation

Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.

PubMed

Rathi, Vinay K; Wang, Bo; Ross, Joseph S; Downing, Nicholas S; Kesselheim, Aaron S; Gray, Stacey T

2017-04-01

Objective The US Food and Drug Administration (FDA) approves indications for prescription drugs based on premarket pivotal clinical studies designed to demonstrate safety and efficacy. We characterized the pivotal studies supporting FDA approval of otolaryngologic prescription drug indications. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects Recently approved (2005-2014) prescription drug indications for conditions treated by otolaryngologists or their multidisciplinary teams. Drugs could be authorized for treatment of otolaryngologic disease upon initial approval (original indications) or thereafter via supplemental applications (supplemental indications). Methods Pivotal studies were categorized by enrollment, randomization, blinding, comparator type, and primary endpoint. Results Between 2005 and 2014, the FDA approved 48 otolaryngologic prescription drug indications based on 64 pivotal studies, including 21 original indications (19 drugs, 31 studies) and 27 supplemental indications (18 drugs, 33 studies). Median enrollment was 299 patients (interquartile range, 198-613) for original indications and 197 patients (interquartile range, 64-442) for supplemental indications. Most indications were supported by ≥1 randomized study (original: 20/21 [95%], supplemental: 21/27 [78%]) and ≥1 double-blinded study (original: 14/21 [67%], supplemental: 17/27 [63%]). About half of original indications (9/21 [43%]) and one-quarter of supplemental indications (7/27 [26%]) were supported by ≥1 active-controlled study. Nearly half (original: 8/21 [38%], supplemental: 14/27 [52%]) of all indications were approved based exclusively on studies using surrogate markers as primary endpoints. Conclusion The quality of clinical evidence supporting FDA approval of otolaryngologic prescription drug indications varied widely. Otolaryngologists should consider limitations in premarket evidence when helping patients make informed

78 FR 76838 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

...) by adding a chapter granting FDA important authority to regulate the manufacture, marketing, and... introduced or delivered for introduction into interstate commerce, a manufacturer must submit a premarket... for introduction into interstate commerce (section 910 of the FD&C Act (21 U.S.C. 387j)). An order...

77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion... events in the overall context of the disease and existing treatment options; (2) to discuss whether...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 880.2920 - Clinical mercury thermometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

21 CFR 172.712 - 1,3-Butylene glycol.

Code of Federal Regulations, 2011 CFR

2011-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... Premarket Approval, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug...

21 CFR 172.712 - 1,3-Butylene glycol.

Code of Federal Regulations, 2012 CFR

2012-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... Premarket Approval, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug...

21 CFR 172.712 - 1,3-Butylene glycol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... Premarket Approval, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2011 CFR

2011-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2013 CFR

2013-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2014 CFR

2014-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2010 CFR

2010-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 880.5630 - Nipple shield.

Code of Federal Regulations, 2012 CFR

2012-04-01

... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... asynchronous devices implanted in the human body. (b) Classification. Class III (premarket approval). (c) Date... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 870.3610 - Implantable pacemaker pulse generator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... asynchronous devices implanted in the human body. (b) Classification. Class III (premarket approval). (c) Date... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implantable pacemaker pulse generator. 870.3610 Section 870.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

75 FR 10294 - Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

...] Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension...). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k... premarket notification (or 510(k)) process for the review of medical devices. Specific questions for comment...

21 CFR 862.1720 - Triose phosphate isomerase test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

21 CFR 862.1720 - Triose phosphate isomerase test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

21 CFR 862.1720 - Triose phosphate isomerase test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

21 CFR 206.7 - Exemptions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... controlled study. Placebos intended for use in a clinical investigation are exempt from the requirements of..., other than reference listed drugs, intended for use in bioequivalence studies. (3) Drugs that are... because of size or unique physical characteristics: (1) For a drug subject to premarket approval, FDA may...

21 CFR 206.7 - Exemptions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... controlled study. Placebos intended for use in a clinical investigation are exempt from the requirements of..., other than reference listed drugs, intended for use in bioequivalence studies. (3) Drugs that are... because of size or unique physical characteristics: (1) For a drug subject to premarket approval, FDA may...

21 CFR 206.7 - Exemptions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... controlled study. Placebos intended for use in a clinical investigation are exempt from the requirements of..., other than reference listed drugs, intended for use in bioequivalence studies. (3) Drugs that are... because of size or unique physical characteristics: (1) For a drug subject to premarket approval, FDA may...

21 CFR 872.6570 - Impression tube.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 177.1585 - Polyestercarbonate resins.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... Polyestercarbonate resins may be safely used as articles or components of articles intended for use in producing.... Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition... examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...

76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... Memorandum titled ``Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,'' a... achieves its intended goals. In September 2009, FDA's Center for Devices and Radiological Health (CDRH... regarding the strengths and challenges associated with the 510(k) program. In August 2010, CDRH published...

77 FR 43842 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-26

...; Irradiation in the Production, Processing, and Handling of Food AGENCY: Food and Drug Administration, HHS.... Irradiation in the Production, Processing, and Handling of Food--21 CFR Part 179 (OMB Control Number 0910-0186.... 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval...

21 CFR 884.5225 - Abdominal decompression chamber.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Abdominal decompression chamber. 884.5225 Section 884.5225 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... abdominal pain during pregnancy or labor. (b) Classification. Class III (premarket approval). (c) Date PMA...

Assessment of the Effects of Climate Change on Federal Hydropower

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sale, Michael J.; Shih-Chieh, Kao; Ashfaq, Moetasim

As directed by Congress in Section 9505 of the SECURE Water Act of 2009 (Public Law 111-11), the US Department of Energy (DOE), in consultation with the federal Power Marketing Administrations (PMAs) and other federal agencies, including federal dam owners, has prepared a comprehensive assessment examining the effects of climate change on water available for hydropower at federal facilities and on the marketing of power from these federal facilities. This Oak Ridge National Laboratory report, referred to as the “9505 Assessment,” describes the technical basis for the report to Congress that was called for in the SECURE Water Act.

Optical, physical and chemical properties of aerosols transported to a coastal site in the western Mediterranean: a focus on primary marine aerosols

NASA Astrophysics Data System (ADS)

Claeys, Marine; Roberts, Greg; Mallet, Marc; Arndt, Jovanna; Sellegri, Karine; Sciare, Jean; Wenger, John; Sauvage, Bastien

2017-06-01

As part of the ChArMEx-ADRIMED campaign (summer 2013), ground-based in situ observations were conducted at the Ersa site (northern tip of Corsica; 533 m a.s.l.) to characterise the optical, physical and chemical properties of aerosols. During the observation period, a major influence of primary marine aerosols was detected (22-26 June), with a mass concentration reaching up to 6.5 µg m-3 and representing more than 40 % of the total PM10 mass concentration. Its relatively low ratio of chloride to sodium (average of 0.57) indicates a fairly aged sea salt aerosol at Ersa. In this work, an original data set, obtained from online real-time instruments (ATOFMS, PILS-IC) has been used to characterise the ageing of primary marine aerosols (PMAs). During this PMA period, the mixing of fresh and aged PMAs was found to originate from both local and regional (Gulf of Lion) emissions, according to local wind measurements and FLEXPART back trajectories. Two different aerosol regimes have been identified: a dust outbreak (dust) originating from Algeria/Tunisia, and a pollution period with aerosols originating from eastern Europe, which includes anthropogenic and biomass burning sources (BBP). The optical, physical and chemical properties of the observed aerosols, as well as their local shortwave (SW) direct radiative effect (DRE) in clear-sky conditions, are compared for these three periods in order to assess the importance of the direct radiative impact of PMAs compared to other sources above the western Mediterranean Basin. As expected, AERONET retrievals indicate a relatively low local SW DRF during the PMA period with mean values of -11 ± 4 at the surface and -8 ± 3 W m-2 at the top of the atmosphere (TOA). In comparison, our results indicate that the dust outbreak observed at our site during the campaign, although of moderate intensity (AOD of 0.3-0.4 at 440 nm and column-integrated SSA of 0.90-0.95), induced a local instantaneous SW DRF that is nearly 3 times the effect

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...

77 FR 34955 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

...'' as ``any substance intended for use as a component of materials used in manufacturing, packing... premarket review of a food additive petition (FAP) under section 409(b) of the FD&C Act is necessary to... notification. Currently, interested persons transmit an FCN submission to the Office of Food Additive Safety in...

21 CFR 177.1360 - Ethylene-vinyl acetate-vinyl alcohol copolymers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Ethylene-vinyl acetate-vinyl alcohol copolymers. 177.1360 Section 177.1360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

21 CFR 886.4300 - Intraocular lens guide.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct... lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2010 CFR

2010-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2011 CFR

2011-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2014 CFR

2014-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2013 CFR

2013-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 886.1200 - Optokinetic drum.

Code of Federal Regulations, 2012 CFR

2012-04-01

... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

21 CFR 170.106 - Notification for a food contact substance formulation (NFCSF).

Code of Federal Regulations, 2014 CFR

2014-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.106 Notification for a... accept an NFCSF, any food additive that is a component of the formulation must be authorized for its... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Notification for a food contact substance...

21 CFR 872.3730 - Pantograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... lower jaw. (b) Classification. Class I (general controls). The device is exempt from the premarket... intended to be attached to a patient's head to duplicate lower jaw movements to aid in construction of restorative and prosthetic dental devices. A marking pen is attached to the lower jaw component of the device...

21 CFR 874.5840 - Antistammering device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 876.5820 - Hemodialysis system and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop..., dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the...

76 FR 76417 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-07

...); biologics; medical devices; dietary supplements and other special nutritional products (e.g., infant formula... supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary supplements do not require premarket approval by FDA and the Agency bears the burden to gather and review evidence that a dietary supplement may...

76 FR 55919 - Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...; dietary supplements and other special nutritional products (e.g., infant formula and medical foods); and... regulates the safety (i.e., adulteration) of dietary supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary supplements do not require premarket approval by FDA and the Agency bears the burden to...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2013 CFR

2013-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2014 CFR

2014-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2012 CFR

2012-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

77 FR 6831 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

... correlation observed by NASDAQ between levels of liquidity provided during pre-market hours and levels... extra rebate with respect to all displayed liquidity provided through a designated MPID that executes at... Execution Ratio'' for the month is less than 10. The PMI Execution Ratio is defined as the ratio of (A) the...

77 FR 8936 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... defined as ``the ratio of (A) the total number of liquidity-providing orders entered by a member through... trading sessions. (3) The ratio between shares of liquidity provided through the MPID and total shares..., or pre-market and/or post- market hours; and to maintain a high ratio of liquidity provision to order...

21 CFR 886.5918 - Rigid gas permeable contact lens care products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Rigid gas permeable contact lens care products. 886.5918 Section 886.5918 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” [62 FR 30987...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 864.6700 - Erythrocyte sedimentation rate test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

21 CFR 177.1637 - Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.

Code of Federal Regulations, 2010 CFR

2010-04-01

... as articles or components of articles intended for use in contact with food in accordance with the... article shall have a minimum inherent viscosity of 0.55 deciliter per gram in a solution of 0.1 gram of... Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration...

21 CFR 880.5090 - Liquid bandage.

Code of Federal Regulations, 2010 CFR

2010-04-01

... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

78 FR 18233 - Medical Devices; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... the right column: Section Remove Add 814.20 http://www.fda.gov/ http://www.fda.gov/ cdrh/devadvice.../ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/ AboutFDA/ dispute.html. CentersOffices/ OfficeofMedicalPr oductsandTobacco/ CDRH/ CDRHOmbudsman/ default.htm. 822.15...

Diagnostic and Therapeutic Cancer Care Equipment

DTIC Science & Technology

2009-07-01

Content of Premarket Submissions for Software Contained in Medical Devices” available at http://www.fda.gov/ cdrh /ode/guidance/337.pdf and “Guidance for...Off-the-Shelf Software Use in Medical Devices” available at http://www.fda.gov/ cdrh /ode/guidance/585.pdf. 5. It is unclear what the “Nellcor Puritan

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing. Food and Drug Administration, HHS. Final rule.

PubMed

2000-04-07

The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.

VizieR Online Data Catalog: CALIFA color/metallicity gradients connections (Marino+, 2016)

NASA Astrophysics Data System (ADS)

Marino, R. A.; Gil de Paz, A.; Sanchez, S. F.; Sanchez-Blazquez, P.; Cardiel, N.; Castillo-Morales, A.; Pascual, S.; Vilchez, J.; Kehrig, C.; Molla, M.; Mendez-Abreu, J.; Catalan-Torrecilla, C.; Florido, E.; Perez, I.; Ruiz-Lara, T.; Ellis, S.; Lopez-Sanchez, A. R.; Gonzalez Delgado, R. M.; de Lorenzo-Caceres, A.; Garcia-Benito, R.; Galbany, L.; Zibetti, S.; Cortijo, C.; Kalinova, V.; Mast, D.; Iglesias-Paramo, J.; Papaderos, P.; Walcher, C. J.; Bland-Hawthorn, J.

2016-03-01

We have selected the 350 galaxies observed by the CALIFA survey (Sanchez et al., 2012A&A...538A...8S) at the CAHA 3.5m telescope with Potsdam Multi Aperture Spectrograph (PMAS) in the PPak mode and processed by the CALIFA v1.5 pipeline up to September 2014. The SDSS g' and r' SB and (g'-r') color profiles were derived using the DR10 data products, in particular, we used the swarp mosaicking code (Ahn et al., 2014ApJS..211...17A). We obtain spectroscopic information for ~15130 HII regions (or complexes) from our 324 CALIFA data cubes using HII explorer. (2 data files).

KSC-97PC1139

NASA Image and Video Library

1997-07-26

The first of two Pressurized Mating Adapters, or PMAs, for the International Space Station arrive in KSC’s Space Station Processing Facility in July. A PMA is a cone-shaped connector that will be attached to Node 1, the space station’s structural building block, during ground processing. The adapter will house space station computers and various electrical support equipment and eventually will serve as the passageway for astronauts between the node and the U.S-financed, Russian-built Functional Cargo Block. Node 1 with two adapters attached will be the first element of the station to be launched aboard the Space Shuttle Endeavour on STS-88 in July 1998

KSC-97PC1140

NASA Image and Video Library

1997-07-26

The first of two Pressurized Mating Adapters, or PMAs, for the International Space Station arrive in KSC’s Space Station Processing Facility in July. A PMA is a cone-shaped connector that will be attached to Node 1, the space station’s structural building block, during ground processing. The adapter will house space station computers and various electrical support equipment and eventually will serve as the passageway for astronauts between the node and the U.S-financed, Russian-built Functional Cargo Block. Node 1 with two adapters attached will be the first element of the station to be launched aboard the Space Shuttle Endeavour on STS-88 in July 1998

Medical Device Recalls: Examination of Selected Cases

DTIC Science & Technology

1989-10-01

thle prodiict (wr elmve it 1rml I hie miarket . !(Ahs nio 881 lniit V iimler I lie F4edrl Food ., I )ig.s anid ( t- mel it Act. als a8iid~edl. 441ll...Premarketing approval?: No Manufact -rer: General Electric Co., Gainesville, FL Problemn Description: Batteries can lose part of their charge after

78 FR 17464 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-21

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69151; File No. SR-NASDAQ-2013-033] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Extend the Pre-Market Hours of the Exchange to 4:00 a.m. EST March 15, 2013. Pursuant to Section 19(b)(1) of the Securities...

21 CFR 807.92 - Content and format of a 510(k) summary.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

21 CFR 807.92 - Content and format of a 510(k) summary.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

21 CFR 807.92 - Content and format of a 510(k) summary.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

21 CFR 807.92 - Content and format of a 510(k) summary.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

21 CFR 807.92 - Content and format of a 510(k) summary.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Content and format of a 510(k) summary. 807.92... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a...

21 CFR 814.46 - Withdrawal of approval of a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval of a PMA. (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act...

21 CFR 814.47 - Temporary suspension of approval of a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order...

21 CFR 814.47 - Temporary suspension of approval of a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order...

21 CFR 814.46 - Withdrawal of approval of a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval of a PMA. (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act...

21 CFR 814.47 - Temporary suspension of approval of a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.47 Temporary suspension of approval of a PMA. (a) Scope. (1) This section describes the procedures that FDA will follow in... the original PMA, as well as any PMA supplement(s), for a medical device. (2) FDA will issue an order...

21 CFR 814.46 - Withdrawal of approval of a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval of a PMA. (a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 807.85 - Exemption from premarket notification.

Code of Federal Regulations, 2011 CFR

2011-04-01

... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially...

21 CFR 807.85 - Exemption from premarket notification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially...

21 CFR 807.85 - Exemption from premarket notification.

Code of Federal Regulations, 2010 CFR

2010-04-01

... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially...

21 CFR 807.85 - Exemption from premarket notification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially...

21 CFR 807.85 - Exemption from premarket notification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially...

Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

PubMed

Ma, Handong; Weng, Chunhua

2016-04-01

To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long

21 CFR 814.44 - Procedures for review of a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.44 Procedures for review of a PMA. Link to an amendment published at 75 FR 16351, Apr. 1, 2010. (a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42. FDA may refer the PMA to a panel on...

21 CFR 814.44 - Procedures for review of a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.44 Procedures for review of a PMA. (a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42. FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an...

21 CFR 814.44 - Procedures for review of a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.44 Procedures for review of a PMA. Link to an amendment published at 79 FR 1740, Jan. 10, 2014. (a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42. FDA may refer the PMA to a panel on...

Regulation of natural health products in Canada.

PubMed

Smith, Alysyn; Jogalekar, Sumedha; Gibson, Adam

2014-12-02

In Canada, all natural health products (NHPs) are regulated by Health Canada (HC) under the Food and Drugs Act and the Natural Health Product Regulations. All authorized products undergo pre-market assessment for safety, efficacy and quality and the degree of pre-market oversight varies depending on the risk of the product. In Canada, over 70,000 products have been authorized for sale and over 2000 sites have been licensed to produce NHPs. In the management of NHPs on the Canadian market, HC employs a number of active and collaborative methods to address the most common issues such as contamination, adulteration and deceptive or misleading advertising practices. HC is currently evolving its approaches to NHPs to recognize them as part of the larger group of health products available without a prescription. As such, the regulatory responsibility for all over-the-counter (OTC) drugs, including non-prescription drugs and NHPs, has been transferred to a single federal division. As a result of this transition a number of benefits are being realized with respect to government efficiency, clarity for industry, support for new innovations and consolidated government interactions with the Canadian market. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Optimizing dosing of oncology drugs.

PubMed

Minasian, L; Rosen, O; Auclair, D; Rahman, A; Pazdur, R; Schilsky, R L

2014-11-01

The purpose of this article is to acknowledge the challenges in optimizing the dosing of oncology drugs and to propose potential approaches to address these challenges in order to optimize effectiveness, minimize toxicity, and promote adherence in patients. These approaches could provide better opportunities to understand the sources of variability in drug exposure and clinical outcomes during the development and premarketing evaluation of investigational new drugs.

A risk-based classification scheme for genetically modified foods. I: Conceptual development.

PubMed

Chao, Eunice; Krewski, Daniel

2008-12-01

The predominant paradigm for the premarket assessment of genetically modified (GM) foods reflects heightened public concern by focusing on foods modified by recombinant deoxyribonucleic acid (rDNA) techniques, while foods modified by other methods of genetic modification are generally not assessed for safety. To determine whether a GM product requires less or more regulatory oversight and testing, we developed and evaluated a risk-based classification scheme (RBCS) for crop-derived GM foods. The results of this research are presented in three papers. This paper describes the conceptual development of the proposed RBCS that focuses on two categories of adverse health effects: (1) toxic and antinutritional effects, and (2) allergenic effects. The factors that may affect the level of potential health risks of GM foods are identified. For each factor identified, criteria for differentiating health risk potential are developed. The extent to which a GM food satisfies applicable criteria for each factor is rated separately. A concern level for each category of health effects is then determined by aggregating the ratings for the factors using predetermined aggregation rules. An overview of the proposed scheme is presented, as well as the application of the scheme to a hypothetical GM food.

Biomaterials Evaluation: Conceptual Refinements and Practical Reforms.

PubMed

Masaeli, Reza; Zandsalimi, Kavosh; Tayebi, Lobat

2018-01-01

Regarding the widespread and ever-increasing applications of biomaterials in different medical fields, their accurate assessment is of great importance. Hence the safety and efficacy of biomaterials is confirmed only through the evaluation process, the way it is done has direct effects on public health. Although every biomaterial undergoes rigorous premarket evaluation, the regulatory agencies receive a considerable number of complications and adverse event reports annually. The main factors that challenge the process of biomaterials evaluation are dissimilar regulations, asynchrony of biomaterials evaluation and biomaterials development, inherent biases of postmarketing data, and cost and timing issues. Several pieces of evidence indicate that current medical device regulations need to be improved so that they can be used more effectively in the evaluation of biomaterials. This article provides suggested conceptual refinements and practical reforms to increase the efficiency and effectiveness of the existing regulations. The main focus of the article is on strategies for evaluating biomaterials in US, and then in EU.

Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing.

PubMed

Yim, Seon-Hee; Chung, Yeun-Jun

2014-12-01

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

Marketing medical devices in Japan.

PubMed

Ohashi, J

1998-01-01

The control of medical devices in Japan has recently undergone significant changes as the country brings its systems into line with those of the United States and Europe. This article discusses pre-market approval, quality system requirements and post-market surveillance. Many technical issues have been harmonized but language is likely to continue to be a barrier to trade. Details of information services that are available to foreign manufacturers and importers are supplied.

Just a Spoonful of Sugar Will Land You Six Feet Underground: Should the Food and Drug Administration Revoke Added Sugar's GRAS Status?

PubMed

Card, Melissa Marie; Abela, John Francis

2015-01-01

This article assesses whether added sugar meets FDA's standard to be generally recognized as safe ("GRAS"). If added sugar is not GRAS, then manufacturers are subject to premarket approval prior to using added sugar in their products. This article advocates that FDA should issue a Federal Register notice determining that added sugar is not GRAS, allowing FDA to regulate the amount of added sugar used in processed foods, decreasing the health adversities that stem from added sugar consumption.

High-Resolution Magic Angle Spinning Nuclear Magnetic Resonance of Intact Zebrafish Embryos Detects Metabolic Changes Following Exposure to Teratogenic Polymethoxyalkenes from Algae

PubMed Central

Roy, Upasana; Jaja-Chimedza, Asha; Sanchez, Kristel; Matysik, Joerg

2016-01-01

Abstract Techniques based on nuclear magnetic resonance (NMR) for imaging and chemical analyses of in vivo, or otherwise intact, biological systems are rapidly emerging and finding diverse applications within a wide range of fields. Very recently, several NMR-based techniques have been developed for the zebrafish as a model animal system. In the current study, the novel application of high-resolution magic angle spinning (HR-MAS) NMR is presented as a means of metabolic profiling of intact zebrafish embryos. Toward investigating the utility of HR-MAS NMR as a toxicological tool, these studies specifically examined metabolic changes of embryos exposed to polymethoxy-1-alkenes (PMAs)—a recently identified family of teratogenic compounds from freshwater algae—as emerging environmental contaminants. One-dimensional and two-dimensional HR-MAS NMR analyses were able to effectively identify and quantify diverse metabolites in early-stage (≤36 h postfertilization) embryos. Subsequent comparison of the metabolic profiles between PMA-exposed and control embryos identified several statistically significant metabolic changes associated with subacute exposure to the teratogen, including (1) elevated inositol as a recognized component of signaling pathways involved in embryo development; (2) increases in several metabolites, including inositol, phosphoryl choline, fatty acids, and cholesterol, which are associated with lipid composition of cell membranes; (3) concomitant increase in glucose and decrease in lactate; and (4) decreases in several biochemically related metabolites associated with central nervous system development and function, including γ-aminobutyric acid, glycine, glutamate, and glutamine. A potentially unifying model/hypothesis of PMA teratogenicity based on the data is presented. These findings, taken together, demonstrate that HR-MAS NMR is a promising tool for metabolic profiling in the zebrafish embryo, including toxicological applications. PMID

Substantial Equivalence Standards in Tobacco Governance: Statutory Clarity and Regulatory Precedent for the FSPTCA.

PubMed

Carpenter, Daniel; Connolly, Gregory N; Lempert, Lauren Kass

2017-08-01

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 creates the first national system of premarket regulation of tobacco products in American history. The FDA must now review and give marketing authorization to all new tobacco products, based on a public health standard, before they can be legally marketed. Yet the law also contains an alternative pathway for market entry-the substantial equivalence (SE) clause-by which novel and altered tobacco products can be marketed by demonstrating their substantial equivalence to existing products. Over 99 percent of tobacco product applications sent to the FDA under the new law have used this mechanism, and loose application of the SE mechanism carries the risk of undoing the FDA's gatekeeping power under the law. We review the statutory and regulatory precedent for SE, examining the FSPTCA itself as well as regulatory precedent from drug and device regulation (from which the term substantial equivalence and much of the associated statutory language was derived). Our review of standards and scientific precedent demonstrates that exacting scrutiny under the public health standard should govern all SE reviews and that clinical data incorporating social scientific evidence should be routinely required for SE claims by tobacco product sponsors. Copyright © 2017 by Duke University Press.

The pharmacist and adverse drug reaction reporting.

PubMed

Pearson, K

1982-08-01

During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.

Regulatory aspects of total product life cycle.

PubMed

Hausman, Ethan D; Altaie, Sousan S

2004-12-01

Total Product Life Cycle (TPLC) is a conceptual framework for assessing any product or service (medical or otherwise). This article will address how the Center for Devices and Radiological Health of the U.S. Food and Drug Administration utilizes TPLC in a regulatory paradigm. TPLC will help guide the regulation of market-driven evolution of medical devices and radiation-emitting products from conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.

Triggered metal ion release and oxidation: Ferrocene as new mechanophore in polymers.

PubMed

Di Giannantonio, Michela; Ayer, Mathieu A; Verde-Sesto, Ester; Lattuada, Marco; Weder, Christoph; Fromm, Katharina M

2018-06-13

The introduction of mechanophores into polymers allows transducing mechanical forces into chemical reactions for e.g. self-healing, catalytic activity, or mechanochromic response. Here, the first example of mechanically induced metal ion release from a polymer is reported. Ferrocene (Fc) was incorporated as an Fe-ion releasing mechanophore into poly(methyl acrylate)s (PMAs) and polyurethanes (PUs). Sonication triggered the preferential cleavage of the polymers at the Fc units over other bonds, as shown by a kinetic study of the molar mass distribution of the cleaved Fc-containing and Fc-free reference polymers. The released and oxidized Fe2+ ions can be detected with KSCN to generate the red-colored [Fe(SCN)n(H2O)6-n)](3-n)+ or reacted with K4[Fe(CN)6] to afford Prussian blue. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

STS-88 Crew Interview: Nancy Currie

NASA Technical Reports Server (NTRS)

1998-01-01

Nancy Currie discusses the seven-day mission that will be highlighted by the mating of the U.S.-built Node 1 station element to the Functional Energy Block (FGB) which will already be in orbit, and two spacewalks to connect power and data transmission cables between the Node and the FGB. Node 1 will be the first Space Station hardware delivered by the Space Shuttle. He also disscusses the assembly sequence. The crew will conduct a series of rendezvous maneuvers similar to those conducted on other Shuttle missions to reach the orbiting FGB. Once the two elements are docked, Ross and Newman will conduct two scheduled spacewalks to connect power and data cables between the Node, PMAs and the FGB. The day following the spacewalks, Endeavour will undock from the two components, completing the first Space Station assembly mission.

21 CFR 807.87 - Information required in a premarket notification submission.

Code of Federal Regulations, 2010 CFR

2010-04-01

... § 807.93. (i) A financial certification or disclosure statement or both, as required by part 54 of this... class III under section 513(b) of the act: (1) Which was introduced or delivered for introduction into.... (Information collection requirements in this section were approved by the Office of Management and Budget (OMB...

77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... inclined platform lifts and vertical platform lifts), classified under 21 CFR 890.3930. IV. Comments...

21 CFR 807.81 - When a premarket notification submission is required.

Code of Federal Regulations, 2010 CFR

2010-04-01

... equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II. (2..., chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the...

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive

[Genetically modified plants and food safety. State of the art and discussion in the European Union].

PubMed

Schauzu, M

2004-09-01

Placing genetically modified (GM) plants and derived products on the European Union's (EU) market has been regulated by a Community Directive since 1990. This directive was complemented by a regulation specific for genetically modified and other novel foods in 1997. Specific labelling requirements have been applicable for GM foods since 1998. The law requires a pre-market safety assessment for which criteria have been elaborated and continuously adapted in accordance with the state of the art by national and international bodies and organisations. Consequently, only genetically modified products that have been demonstrated to be as safe as their conventional counterparts can be commercialized. However, the poor acceptance of genetically modified foods has led to a de facto moratorium since 1998. It is based on the lack of a qualified majority of EU member states necessary for authorization to place genetically modified plants and derived foods on the market. New Community Regulations are intended to end this moratorium by providing a harmonized and transparent safety assessment, a centralised authorization procedure, extended labelling provisions and a traceability system for genetically modified organisms (GMO) and derived food and feed.

Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework.

PubMed

Abdel-Tawab, Mona

2018-04-01

Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission. Georg Thieme Verlag KG Stuttgart · New York.

Important statistical considerations in the evaluation of post-market studies to assess whether opioids with abuse-deterrent properties result in reduced abuse in the community.

PubMed

By, Kunthel; McAninch, Jana K; Keeton, Stephine L; Secora, Alex; Kornegay, Cynthia J; Hwang, Catherine S; Ly, Thomas; Levenson, Mark S

2018-05-01

Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community. Utilizing data from various surveillance systems, some recent post-market studies suggest a decline in abuse of extended-release oxycodone after reformulation with abuse-deterrent properties. We discuss challenges stemming from the use of such data. We quantify the relationship between the sample, the population, and the underlying sampling mechanism and identify the necessary conditions if valid statements about the population are to be made. The presence of other interventions in the community necessitates the use of comparators. We discuss the principles under which the use of comparators can be meaningful. Results based on surveillance data need to be interpreted with caution as the underlying sampling mechanisms can bias the results in unpredictable ways. The use of comparators has the potential to disentangle the effect due to the abuse-deterrence properties from those due to other interventions. However, identifying a comparator that is meaningful can be very difficult. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Preventing postmarketing changes in recommended doses and marketing withdrawals.

PubMed

Peck, C

2007-01-01

Recent market withdrawals of prescription drug products have brought attention to premarketing safety research. Less known but related to some drug withdrawals are postmarketing dosage changes of newly marketed drugs, including both dosage reductions and increases. These events have serious effects on patients, manufacturers, and regulatory authorities. Most of these harmful events could be avoided by intensive employment of targeted clinical pharmacology investigations to optimize dosage prior to phase III testing and regulatory approval. In this paper, the frequency and implications of postmarketing dosing changes and market withdrawals are considered in light of approaches to preventing them.

Current status of herbal product: Regulatory overview

PubMed Central

Sharma, Sanjay

2015-01-01

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

Current status of herbal product: Regulatory overview.

PubMed

Sharma, Sanjay

2015-01-01

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment.

Lightning protection: challenges, solutions and questionable steps in the 21st century

NASA Astrophysics Data System (ADS)

Berta, István

2011-06-01

Besides the special primary lightning protection of extremely high towers, huge office and governmental buildings, large industrial plants and resident parks most of the challenges were connected to the secondary lightning protection of sensitive devices in Information and Communication Technology. The 70 year history of Budapest School of Lightning Protection plays an important role in the research and education of lightning and development of lightning protection. Among results and solutions the Rolling Sphere designing method (RS) and the Probability Modulated Attraction Space (PMAS) theory are detailed. As a new field Preventive Lightning Protection (PLP) has been introduced. The PLP method means the use of special preventive actions only for the duration of the thunderstorm. Recently several non-conventional lightning protection techniques have appeared as competitors of the air termination systems formed of conventional Franklin rods. The questionable steps, non-conventional lightning protection systems reported in the literature are the radioactive lightning rods, Early Streamer Emission (ESE) rods and Dissipation Arrays (sometimes called Charge Transfer Systems).

Techniques for reducing fiber-fed and integral-field spectroscopy data: An implementation on R3D

NASA Astrophysics Data System (ADS)

Sánchez, S. F.

2006-11-01

This paper describes the general characteristics of raw data from fiber-fed spectrographs in general and fiber-fed IFUs in particular. The different steps of the data reduction are presented, and the techniques used to address the unusual characteristics of these data are described in detail. These techniques have been implemented in a specialized software package, R3D, developed to reduce fiber-based integral field spectroscopy (IFS) data. The package comprises a set of command-line routines adapted for each of these steps, suitable for creating pipelines. The routines have been tested against simulations, and against real data from various integral field spectrographs (PMAS, PPAK, GMOS, VIMOS and INTEGRAL). Particular attention is paid to the treatment of cross-talk. Based on observations collected at the Centro Astronḿico Hispano Alemán (CAHA) at Calar Alto, operated jointly by the Max-Planck Institut für Astronomie and the Instituto de Astrofísica de Andalucía (CSIC).

76 FR 32214 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-03

... a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to FDA upon which it has based its conclusion that a dietary supplement containing a new dietary... delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary...

78 FR 52773 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to us upon which it has based its conclusion that a dietary supplement containing a new dietary... delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary...

75 FR 32476 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0250... Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain..., [email protected]fda.hhs.gov . SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal...

Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

PubMed

Caliendo, Angela M; Hanson, Kimberly E

2016-04-01

Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Retrospective analysis of RF heating measurements of passive medical implants.

PubMed

Song, Ting; Xu, Zhiheng; Iacono, Maria Ida; Angelone, Leonardo M; Rajan, Sunder

2018-05-09

The test reports for the RF-induced heating of metallic devices of hundreds of medical implants have been provided to the U.S. Food and Drug Administration as a part of premarket submissions. The main purpose of this study is to perform a retrospective analysis of the RF-induced heating data provided in the reports to analyze the trends and correlate them with implant geometric characteristics. The ASTM-based RF heating test reports from 86 premarket U.S. Food and Drug Administration submissions were reviewed by three U.S. Food and Drug Administration reviewers. From each test report, the dimensions and RF-induced heating values for a given whole-body (WB) specific absorption rate (SAR) and local background (LB) SAR were extracted and analyzed. The data from 56 stents were analyzed as a subset to further understand heating trends and length dependence. For a given WB SAR, the LB/WB SAR ratio varied significantly across the test labs, from 2.3 to 11.3. There was an increasing trend on the temperature change per LB SAR with device length. The maximum heating for stents occurred at lengths of approximately 100 mm at 3 T, and beyond 150 mm at 1.5 T. Differences in the LB/WB SAR ratios across testing labs and various MRI scanners could lead to inconsistent WB SAR labeling. Magnetic resonance (MR) conditional labeling based on WB SAR should be derived from a conservative estimate of global LB/WB ratios. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

Can we well assess the relative efficacy and tolerability of a new drug versus others at the time of marketing authorization using mixed treatment comparisons? A detailed illustration with escitalopram.

PubMed

Llorca, Pierre-Michel; Lançon, Christophe; Brignone, Mélanie; Painchault, Caroline; Rive, Benoit; Toumi, Mondher; François, Clément

2015-01-01

To assess the variation of relative efficacy and tolerability of an antidepressant versus others based on both pre-marketing (registration studies) and post-marketing studies versus pre-marketing studies only in patients with major depressive disorder. The relative efficacy and tolerability of antidepressants was assessed by mixed treatment comparisons (MTCs) using data acquired over two time periods: before registration of the reference drug escitalopram (1989-2002) and up to 5 years later (1989-2007). Ranking probability outputs were presented for efficacy, using change from baseline to 8 weeks on Montgomery-Åsberg Depression Rating Scale total score, and tolerability, using withdrawals due to adverse events. The relative efficacy and tolerability of some selected antidepressants, including escitalopram, varied considerably over the two time periods. The improved relative efficacy and tolerability of escitalopram over time, compared with citalopram, was demonstrated by greater separation of ranking probability curves for efficacy and tolerability. In 2002, escitalopram ranked low with 13.9% and 5.1% probability of being in the top four antidepressants' relative efficacy and tolerability, respectively. In 2007, ranking probabilities for relative efficacy and tolerability of escitalopram increased to 52.5% and 82.1%, respectively. Time of marketing authorization may not be the most appropriate time to evaluate the relative efficacy and tolerability of a new antidepressant based on MTC approach due to the asymmetry of information between new and older compounds. However, the first evaluation of relative effect of a new drug for health technology assessment recommendations is commonly done at this time. Re-evaluation of a drug several years after its launch is likely to provide a more accurate indication of its relative efficacy and tolerability.

3-D bioprinting law regulation perspectives.

PubMed

Pashkov, Vitalii; Harkusha, Andrii

Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. General debate of last few years comes down to an attempt to resolve hesitation between legal attempts for regulation of 3-D biobrinting and concept of complete prohibition of such activities. An adequate response to the mentioned challenge is a reasonable position between some aspects of prohibition and self-regulation, resulting in a moderate number of regulations and standards for developing and marketing. Such regulations may concern an intellectual property (IP) rights, regulation of distribution, premarket restrictions, control mechanism etc. Scientific approach and regulatory settlement of 3-D bioprinting sphere must unite to achieve a fair balance between the interests of humanity and of individuals - on the one hand, and development of science and business benefits for stakeholders - on the other. The main instruments for this must be balanced regulation of intellectual property (IP) rights, regulation of access and distribution, premarket restrictions, control mechanism etc.

Technology assessment and the Food and Drug Administration

NASA Technical Reports Server (NTRS)

Kaplan, A. H.; Becker, R. H.

1972-01-01

The statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.

[Regulation of food supplements in the European Union and its member states. Part I].

PubMed

Petrenko, A S; Ponomareva, M N; Sukhanov, B P

2014-01-01

The article discusses aspects of the regional (the European Union) and national (European countries) regulation of food supplements. The definition of the supplement category is given. The contemporary issues of nutrition in developed countries are discussed, and the essential role of food supplements in the diet is emphasized. In particular, the use of vitamins, minerals, botanicals and their chemical constituents in food supplements as well as the issue of setting maximum daily limits are discussed. The positive lists of vitamins, minerals and their chemical modifications are presented. The paper also outlines aspects of supplement safety, requirements for their labelling and pre-market notification procedure.

Reducing the staggering costs of environmental disease in children, estimated at $76.6 billion in 2008.

PubMed

Trasande, Leonardo; Liu, Yinghua

2011-05-01

A 2002 analysis documented $54.9 billion in annual costs of environmentally mediated diseases in US children. However, few important changes in federal policy have been implemented to prevent exposures to toxic chemicals. We therefore updated and expanded the previous analysis and found that the costs of lead poisoning, prenatal methylmercury exposure, childhood cancer, asthma, intellectual disability, autism, and attention deficit hyperactivity disorder were $76.6 billion in 2008. To prevent further increases in these costs, efforts are needed to institute premarket testing of new chemicals; conduct toxicity testing on chemicals already in use; reduce lead-based paint hazards; and curb mercury emissions from coal-fired power plants.

Medicare and Amyloid PET Imaging: The Battle Over Evidence.

PubMed

Maschke, Karen J; Gusmano, Michael K

2017-01-01

We examine a recent dispute regarding the Centers for Medicare and Medicaid Services' (CMS) refusal to unconditionally pay for amyloid positron emission tomography (PET) imaging for Medicare beneficiaries being assessed for Alzheimer's disease. CMS will only pay for amyloid PET imaging when patients are enrolled in clinical trials that meet certain criteria. The dispute reflects CMS's willingness in certain circumstances to require effectiveness evidence that differs from the Food and Drug Administration's standard for pre-market approval of a medical intervention and reveals how stakeholders with differing perspectives about evidentiary standards have played a role in attempting to shape the Medicare program's coverage policies.

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

PubMed

Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

Predicting and detecting adverse drug reactions in old age: challenges and opportunities.

PubMed

Mangoni, Arduino A

2012-05-01

Increased, often inappropriate, drug exposure, pharmacokinetic and pharmacodynamic changes, reduced homeostatic reserve and frailty increase the risk of adverse drug reactions (ADRs) in the older population, thereby imposing a significant public health burden. Predicting and diagnosing ADRs in old age presents significant challenges for the clinician, even when specific risk scoring systems are available. The picture is further compounded by the potential adverse impact of several drugs on more 'global' health indicators, for example, physical function and independence, and the fragmentation of care (e.g., increased number of treating doctors and care transitions) experienced by older patients during their clinical journey. The current knowledge of drug safety in old age is also curtailed by the lack of efficacy and safety data from pre-marketing studies. Moreover, little consideration is given to individual patients' experiences and reporting of specific ADRs, particularly in the presence of cognitive impairment. Pending additional data on these issues, the close review and monitoring of individual patients' drug prescribing, clinical status and biochemical parameters remain essential to predict and detect ADRs in old age. Recently developed strategies, for example, medication reconciliation and trigger tool methodology, have the potential for ADRs risk mitigation in this population. However, more information is required on their efficacy and applicability in different healthcare settings.

Application submission date reflects applicant quality.

PubMed

Fuhrman, George M; Dada, Stephen; Ehleben, Carole

2008-01-01

Applications for general surgery residency are submitted through the Electronic Residency Application Service (ERAS) beginning in early September. The purpose of this study was to determine whether the date of application submission could be used in the screening of an applicant for general surgery residency. The 2007 ERAS data for an independent program that accepts 2 categorical residents per year was evaluated. International medical graduates were excluded because no international applicants were considered for interviews. Applicants for preliminary positions were also excluded. The remaining graduates from medical schools accredited by the Liaison Committee on Medical Education (LCME) who applied for categorical positions were evaluated based on United States Medical Licensing Examination (USMLE) scores and on medical school performance, as well as on the quality of their personal statements and letters of recommendation. Medical school performance was determined from dean's letters and transcript information, and each applicant was classified as outstanding, average, or poor. The date of application submission was compared with USMLE scores and medical school performance. The lag time to submit an application was also evaluated and compared with whether a student was offered an interview and the assessment of the quality of that interview. Results were evaluated using analysis of variance and the Pearson correlation test to evaluate for significance. A total of 155 applications from LCME-accredited schools for categorical positions were received. The mean lag time to application for students with an outstanding medical school performance was 15.2 +/- 15.5 days compared with 37.4 +/- 26.2 days for poorly performing students (p < 0.01). A negative correlation between USMLE score and the lag time to application was noted (p < 0.01 USMLE I and USMLE II). Applicants offered an interview demonstrated a lag time to submit their application of 19.2 days +/- 21

40 CFR 194.15 - certification application(s).

Code of Federal Regulations, 2010 CFR

1996-07-01

... 40 PROTECTION OF ENVIRONMENT 12 1996-07-01 1996-07-01 false certification application(s). 194.15 Sec. 194.15 Content of compliance re PROTECTION OF ENVIRONMENT ENVIRONMENTAL PROTECTION AGENCY... and Re-certification Applications Sec. 194.15 Content of compliance re-certification application(s...

Current regulatory issues in cell and tissue therapy.

PubMed

Burger, S R

2003-01-01

Cell-based therapies have grown dramatically in power and scope in recent years. Once limited to blood and BM transplantation, these therapies now encompass tissue repair and regeneration, metabolic support, gene replacement, and immune effector functions, with established and investigational clinical applications in disorders affecting nearly every tissue and organ system. The complexity and novel applications of human cells, tissues, and cellular and tissue-based products (HCT/Ps), however, present potential risks for adverse events. The US Food and Drug Administration, responding to these concerns, has established a tiered, risk-based regulatory structure, in which more rigorous controls and safeguards are required for products thought to pose increased risk. The proposed good tissue practices (GTP) rule and existing good manufacturing practices (GMP) requirements form the principal elements of this regulatory framework. The proposed GTPs are intended to prevent HCT/P contamination with infectious disease agents, and to ensure that these cells and tissues maintain their integrity and function. GMPs focus on production of safe, pure, and potent products, and entail a higher level of process control and product characterization. All HCT/Ps will be required to comply with GTPs. HCT/Ps considered to present greater risks of adverse events, however, will be subject to both GTPs and GMPs, and must obtain premarket approval using the Investigational New Drug (IND) mechanism established for biologics. Although these requirements will present significant challenges for clinician- investigators and laboratories producing HCT/Ps, the regulations fundamentally support good clinical care by increasing safety and control, and enable good science by improving the quality and reliability of data.

Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence.

PubMed

Braithwaite, Gavin J C; Daley, Michael J; Toledo-Velasquez, David

2016-01-01

Hyaluronic acid of various molecular weights has been in use for the treatment of osteoarthritis knee pain for decades. Worldwide, these products are regulated as either as drugs or devices and in some countries as both. In the US, this class of products is regulated as Class III medical devices, which places specific regulatory requirements on developers of these materials under a Pre-Market Approval process, typically requiring data from prospective randomized controlled clinical studies. In 1984 pharmaceutical manufacturers became able to file an Abbreviated New Drug Application for approval of a generic drug, thus establishing standards for demonstrating equivalence to an existing chemical entity. Recently, the first biosimilar, or 'generic biologic', was approved. Biosimilars are biological products that are approved by the FDA because they are 'highly similar' to a reference product, and have been shown to have no clinically meaningful differences from the reference product. For devices, Class II medical devices have a pathway for declaring equivalence to an existing product by filing a 510 k application for FDA clearance. However, until recently no equivalent regulatory pathway was available to Class III devices. In this paper, we consider the critical mechanical performance parameters for intra-articular hyaluronic products to demonstrate indistinguishable characteristics. Analogous to the aforementioned pathways that allow for a demonstration of equivalence, we examine these parameters for an existing, marketed device and compare molecular weight and rheological properties of multiple batches of a similar product. We propose that this establishes a scientific rationale for establishing Class III medical device equivalence.

Can we well assess the relative efficacy and tolerability of a new drug versus others at the time of marketing authorization using mixed treatment comparisons? A detailed illustration with escitalopram

PubMed Central

Llorca, Pierre-Michel; Lançon, Christophe; Brignone, Mélanie; Painchault, Caroline; Rive, Benoit; Toumi, Mondher; François, Clément

2015-01-01

Objective To assess the variation of relative efficacy and tolerability of an antidepressant versus others based on both pre-marketing (registration studies) and post-marketing studies versus pre-marketing studies only in patients with major depressive disorder. Methods The relative efficacy and tolerability of antidepressants was assessed by mixed treatment comparisons (MTCs) using data acquired over two time periods: before registration of the reference drug escitalopram (1989–2002) and up to 5 years later (1989–2007). Ranking probability outputs were presented for efficacy, using change from baseline to 8 weeks on Montgomery–Åsberg Depression Rating Scale total score, and tolerability, using withdrawals due to adverse events. Results The relative efficacy and tolerability of some selected antidepressants, including escitalopram, varied considerably over the two time periods. The improved relative efficacy and tolerability of escitalopram over time, compared with citalopram, was demonstrated by greater separation of ranking probability curves for efficacy and tolerability. In 2002, escitalopram ranked low with 13.9% and 5.1% probability of being in the top four antidepressants’ relative efficacy and tolerability, respectively. In 2007, ranking probabilities for relative efficacy and tolerability of escitalopram increased to 52.5% and 82.1%, respectively. Conclusions Time of marketing authorization may not be the most appropriate time to evaluate the relative efficacy and tolerability of a new antidepressant based on MTC approach due to the asymmetry of information between new and older compounds. However, the first evaluation of relative effect of a new drug for health technology assessment recommendations is commonly done at this time. Re-evaluation of a drug several years after its launch is likely to provide a more accurate indication of its relative efficacy and tolerability. PMID:27123184

Surveillance of Salmonella enteritidis in layer houses: a retrospective comparison of the Food and Drug Administration's egg safety rule (2010-2011) and the California Egg Quality Assurance Program (2007-2011).

PubMed

Pitesky, Maurice; Charlton, Bruce; Bland, Mark; Rolfe, Dan

2013-03-01

Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs.

Incorporating patient-preference evidence into regulatory decision making.

PubMed

Ho, Martin P; Gonzalez, Juan Marcos; Lerner, Herbert P; Neuland, Carolyn Y; Whang, Joyce M; McMurry-Heath, Michelle; Hauber, A Brett; Irony, Telba

2015-10-01

Patients have a unique role in deciding what treatments should be available for them and regulatory agencies should take their preferences into account when making treatment approval decisions. This is the first study designed to obtain quantitative patient-preference evidence to inform regulatory approval decisions by the Food and Drug Administration Center for Devices and Radiological Health. Five-hundred and forty United States adults with body mass index (BMI) ≥ 30 kg/m(2) evaluated tradeoffs among effectiveness, safety, and other attributes of weight-loss devices in a scientific survey. Discrete-choice experiments were used to quantify the importance of safety, effectiveness, and other attributes of weight-loss devices to obese respondents. A tool based on these measures is being used to inform benefit-risk assessments for premarket approval of medical devices. Respondent choices yielded preference scores indicating their relative value for attributes of weight-loss devices in this study. We developed a tool to estimate the minimum weight loss acceptable by a patient to receive a device with a given risk profile and the maximum mortality risk tolerable in exchange for a given weight loss. For example, to accept a device with 0.01 % mortality risk, a risk tolerant patient will require about 10 % total body weight loss lasting 5 years. Patient preference evidence was used make regulatory decision making more patient-centered. In addition, we captured the heterogeneity of patient preferences allowing market approval of effective devices for risk tolerant patients. CDRH is using the study tool to define minimum clinical effectiveness to evaluate new weight-loss devices. The methods presented can be applied to a wide variety of medical products. This study supports the ongoing development of a guidance document on incorporating patient preferences into medical-device premarket approval decisions.

An industry update: what is the latest news in the therapeutic delivery field?

PubMed

Reis, Catarina Pinto

2018-05-01

The present industry update covers the period 1-31 December 2017. Information was sourced primarily from scientific literature and various news websites, company press releases, regulatory and patent agencies. The most representative (not all) examples of research are herein described and they are mainly focused on metabolic diseases, cancer, blood pressure diseases, eyes diseases and, in some cases, in rare diseases. In this paper, there was a clear positive approval tendency for several companies where they offered novel therapeutic delivery candidates. Some patents related to the therapeutic field were also published during this month. Finally, the US FDA announced the availability of a draft guidance for industry for products containing nanomaterials (investigational, pre-market and post-market submissions).

Fillers in the skin of color population.

PubMed

Heath, Candrice R; Taylor, Susan C

2011-05-01

The skin of color population in the United States is rapidly growing and the cosmetic industry is responding to the demand for skin of color targeted treatments. The aging face in skin of color patients has a unique pattern that can be successfully augmented by dermal fillers. Though many subjects with skin of color were not included in the pre-market dermal filler clinical trials, some post-market studies have examined the safety and risks of adverse events in this population. The safety data from a selection of these studies was examined. Though pigmentary changes occurred, there have been no reports of keloid development. Developing a patient-specific care plan and instituting close follow up is emphasized.

FDA marketing claims, and the practitioner.

PubMed

Runner, Susan

2006-03-01

The Food and Drug Administration (FDA) is the federal agency that is tasked with regulating market entry for medical devices. The laws that govern this process are codified in the Federal Food Drug and Cosmetic Act (the Act) and the regulations are based on this law. The medical device amendments to the Act were instituted in 1976, instituting the methods for classification of medical devices and the format for the premarket review of devices. Information for practitioners on how medical devices come to market, what data are required, how specific claims are cleared, and how the practitioner can give input to the system are critical for the further development of safe and effective medical devices.

Certain aspects on medical devices software law regulation.

PubMed

Pashkov, Vitalii; Harkusha, Andrii

some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

37 CFR 1.421 - Applicant for international application.

Code of Federal Regulations, 2010 CFR

2010-07-01

... application. 1.421 Section 1.421 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES International Processing Provisions Who May File An International Application § 1.421 Applicant for international application. (a) Only residents...

Review of the regulation and safety assessment of food substances in various countries and jurisdictions.

PubMed

Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

2013-01-01

This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.

Review of the regulation and safety assessment of food substances in various countries and jurisdictions

PubMed Central

Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

2013-01-01

This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843

Medical regulation of cognitive enhancement devices: some concerns

PubMed Central

King, Mike; Gavaghan, Colin; McMillan, John

2014-01-01

The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration. PMID:27774173

Strengthening medical product regulation in low- and middle-income countries.

PubMed

Preston, Charles; Valdez, Mary Lou; Bond, Katherine

2012-01-01

In summary, the case studies exploring global product supply chains and diethylene glycol poisoning in Panama, clinical trials regulation through AVAREF, premarket assurance through PEPFAR tentative approval, post-market surveillance in sub-Saharan Africa through research on drug and vaccine safety systems, and regulatory science through the creation of a low-cost meningitis vaccine for low- and middle-income countries, demonstrate the essential value of regulatory systems to low- and middle-income countries. When they work, people live; when they fail, people die. As the challenges of globalization mount, and efforts to provide medical products to low- and middle-income countries scale up, there is no better time to put regulatory system strengthening squarely on the global health and development agenda.

Applicant Perspectives on the Otolaryngology Residency Application Process.

PubMed

Ward, Matthew; Pingree, Christian; Laury, Adrienne M; Bowe, Sarah N

2017-08-01

It has been nearly 25 years since medical students were queried regarding their perspectives on otolaryngology-head and neck surgery (OHNS) residency selection. Understanding this viewpoint is critical to improving the current application process. To evaluate the perceptions of 2016 OHNS residency applicants regarding the application process and offer suggestions for reform. In this cross-sectional study of anonymous online survey data, a 14-question survey was designed based on resources obtained from a computerized PubMed, Ovid, and GoogleScholar database search of the English language from January 1, 1990, through December 31, 2015, was conducted using the following search terms: (medical student OR applicant) AND (application OR match) AND otolaryngology. The survey was administered to 2016 OHNS residency applicants to examine 4 primary areas: current attitudes toward the match, effect of the new Otolaryngology Program Directors Organization personal statement mandate, sources of advice and information, and suggestions for improvement. In January 2016, an email was sent to 100 program directors asking them to distribute the survey to current OHNS applicants at their institution. One follow-up reminder email was sent in February 2016. A link to the survey was posted on the Otomatch.com homepage on January 28, 2016, with the last response received on March 28, 2016. Survey responses regarding the residency application process. A total of 150 of 370 residency applicants (40.5%) responded to the survey. Of these, 125 respondents (90.6%) noted applying to programs in which they had no specific interest simply to improve their chances of matching. Applicants intended to apply to more programs than they actually did (63.6 vs 60.8; r = 0.19; 95% CI, -0.03 to 0.40). Program directors advised fewer applications than other sources; however, 58 respondents (38.7%) did not receive advice from a program director. A total of 121 respondents (80.7%) found online program

78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462... Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave..... ABI 7500 Fast DX Real-Time PCR Instrument. P060028, FDA-2013-M-0738..... Mentor Worldwide LLC...

76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

.......... Medtronic Vascular.... Valiant thoracic stent graft April 1, 2011. system. H100002 FDA-2011-M-0241... Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire..., 2011. toric IOL. P040012 (S34) FDA-2011-M-0343. Abbott Vascular, Inc.. RX Acculink carotid stent system...