42 CFR 84.64 - Pretesting by applicant; approval of test methods.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Pretesting by applicant; approval of test methods. 84.64 Section 84.64 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

7 CFR 868.209 - Information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 7 2012-01-01 2012-01-01 false Information. 868.209 Section 868.209 Agriculture... Application of Standards § 868.209 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.209 - Information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 7 2013-01-01 2013-01-01 false Information. 868.209 Section 868.209 Agriculture... Application of Standards § 868.209 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.309 - Information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 7 2014-01-01 2014-01-01 false Information. 868.309 Section 868.309 Agriculture... Application of Standards § 868.309 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.309 - Information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 7 2012-01-01 2012-01-01 false Information. 868.309 Section 868.309 Agriculture... Application of Standards § 868.309 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.209 - Information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 7 2011-01-01 2011-01-01 false Information. 868.209 Section 868.209 Agriculture... Application of Standards § 868.209 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.309 - Information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 7 2013-01-01 2013-01-01 false Information. 868.309 Section 868.309 Agriculture... Application of Standards § 868.309 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.209 - Information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 7 2014-01-01 2014-01-01 false Information. 868.209 Section 868.209 Agriculture... Application of Standards § 868.209 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.309 - Information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 7 2011-01-01 2011-01-01 false Information. 868.309 Section 868.309 Agriculture... Application of Standards § 868.309 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.309 - Information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Information. 868.309 Section 868.309 Agriculture... Application of Standards § 868.309 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.209 - Information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Information. 868.209 Section 868.209 Agriculture... Application of Standards § 868.209 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved devices, and...

7 CFR 868.207 - Moisture.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Application of Standards § 868.207 Moisture. Water content in rough rice as determined by an approved device..., “approved device” shall include the Motomco Moisture Meter and any other equipment that is approved by the...

42 CFR 84.10 - Application procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Application procedures. 84.10 Section 84.10 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.10...

42 CFR 84.10 - Application procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Application procedures. 84.10 Section 84.10 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.10...

42 CFR 84.10 - Application procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Application procedures. 84.10 Section 84.10 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.10...

42 CFR 84.10 - Application procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Application procedures. 84.10 Section 84.10 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.10...

42 CFR 84.10 - Application procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Application procedures. 84.10 Section 84.10 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.10...

Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.

PubMed

Wild, Claudia; Erdös, Judit; Zechmeister, Ingrid

2014-11-04

European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices. Since no information is available on clinical data used by the Notified Body for CE-marking, data from Austrian pre-reimbursement assessments close to European market approval were used as proxy and compared with clinical data available at time of market approval by FDA in the USA. 10 cardio-vascular interventions with 27 newly CE approved medical devices were analysed. The time lag between market authorisation in Europe and in the USA is 3 to 7 years. Only 7 CE-marked devices also hold a FDA market approval, 7 further devices are in FDA approved ongoing efficacy trials. For 4 of the CE-marked devices the FDA market application or the approval-trial was either suspended due to efficacy or safety concerns or the approval was denied. Evidence available at time of CE-marking are most often case-series or small feasibility RCTs, while large RCTs and only in rare cases prospective cohort studies are the basis of FDA approvals. Additionally, the FDA often requires post-approval studies for high-risk devices. Market authorisation based on mature clinical data deriving from larger RCTs and longer follow-ups do not only change the perspective on the risk-benefit ratio, but also secures real patient benefit and safety and assures payers of investing only in truly innovative devices.

The nightmare of FDA clearance/approval to market: perception or reality?

PubMed

Tylenda, C A

1996-09-01

Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.

Radiation Effects in III-V Nanowire Devices

DTIC Science & Technology

2016-09-01

Nanowire Devices Distribution Statement A. Approved for public release; distribution is unlimited. September 2016 HDTRA1-11-1-0021 Steven R...Name: Prof. S. R. J. Brueck Organization/Institution: University of New Mexico Project Title: Radiation Effects in III-V Nanowire Devices What are...the agency approved application or plan. The objectives of this program were to: a) develop a new nanowire transistor technology based on nanoscale

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."

42 CFR 84.11 - Contents of application.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Contents of application. 84.11 Section 84.11 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.11...

42 CFR 84.11 - Contents of application.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Contents of application. 84.11 Section 84.11 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.11...

42 CFR 84.11 - Contents of application.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Contents of application. 84.11 Section 84.11 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.11...

42 CFR 84.11 - Contents of application.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Contents of application. 84.11 Section 84.11 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.11...

42 CFR 84.11 - Contents of application.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Contents of application. 84.11 Section 84.11 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Application for Approval § 84.11...

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.

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

21 CFR 812.30 - FDA action on applications.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

PubMed

Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.

27 CFR 479.64 - Procedure for approval of application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.64 - Procedure for approval of application.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.64 - Procedure for approval of application.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.64 - Procedure for approval of application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.64 - Procedure for approval of application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Procedure for approval of application. 479.64 Section 479.64 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

Practice of Regulatory Science (Development of Medical Devices).

PubMed

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

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...

7 CFR 868.207 - Moisture.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 7 2012-01-01 2012-01-01 false Moisture. 868.207 Section 868.207 Agriculture... Application of Standards § 868.207 Moisture. Water content in rough rice as determined by an approved device..., “approved device” shall include the Motomco Moisture Meter and any other equipment that is approved by the...

7 CFR 868.207 - Moisture.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 7 2014-01-01 2014-01-01 false Moisture. 868.207 Section 868.207 Agriculture... Application of Standards § 868.207 Moisture. Water content in rough rice as determined by an approved device..., “approved device” shall include the Motomco Moisture Meter and any other equipment that is approved by the...

7 CFR 868.207 - Moisture.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 7 2013-01-01 2013-01-01 false Moisture. 868.207 Section 868.207 Agriculture... Application of Standards § 868.207 Moisture. Water content in rough rice as determined by an approved device..., “approved device” shall include the Motomco Moisture Meter and any other equipment that is approved by the...

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...

RESNA Position on the Application of Seat-Elevating Devices for Wheelchair Users

ERIC Educational Resources Information Center

Arva, Julianna; Schmeler, Mark R.; Lange, Michelle L.; Lipka, Daniel D.; Rosen, Lauren E.

2009-01-01

This document, approved by the Rehabilitation Engineering & Assistive Technology Society of North America (RESNA) Board of Directors in September 2005, shares typical clinical applications and provides evidence from the literature supporting the use of seat-elevating devices for wheelchair users. Wheelchair mobility is often only considered from…

7 CFR 868.260 - Information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 7 2013-01-01 2013-01-01 false Information. 868.260 Section 868.260 Agriculture... Governing Application of Standards § 868.260 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved...

7 CFR 868.260 - Information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 7 2011-01-01 2011-01-01 false Information. 868.260 Section 868.260 Agriculture... Governing Application of Standards § 868.260 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved...

7 CFR 868.260 - Information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 7 2014-01-01 2014-01-01 false Information. 868.260 Section 868.260 Agriculture... Governing Application of Standards § 868.260 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved...

7 CFR 868.260 - Information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 7 2012-01-01 2012-01-01 false Information. 868.260 Section 868.260 Agriculture... Governing Application of Standards § 868.260 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved...

7 CFR 868.260 - Information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Information. 868.260 Section 868.260 Agriculture... Governing Application of Standards § 868.260 Information. Requests for the Rice Inspection Handbook, Equipment Handbook, or for information concerning approved devices and procedures, criteria for approved...

Novel NI-Based Ohmic Contacts To a-SiC for High Temperature and High Power Device Applications

DTIC Science & Technology

2002-01-01

Temperature and High Power Device Applications DISTRIBUTION: Approved for public release, distribution unlimited This paper is part of the following report...retained omnicity after 100 h of aging and was found to be chemically and microstructurally stable. These findings indicate that the 1000,’C annealed

40 CFR 60.5195 - By what date must I conduct the initial air pollution control device inspection and make any...

Code of Federal Regulations, 2014 CFR

2014-07-01

... air pollution control device inspection and make any necessary repairs? 60.5195 Section 60.5195... air pollution control device inspection and make any necessary repairs? (a) You must conduct an air... approved state plan, Federal plan, or delegation, as applicable. For air pollution control devices...

40 CFR 60.5195 - By what date must I conduct the initial air pollution control device inspection and make any...

Code of Federal Regulations, 2013 CFR

2013-07-01

... air pollution control device inspection and make any necessary repairs? 60.5195 Section 60.5195... air pollution control device inspection and make any necessary repairs? (a) You must conduct an air... approved state plan, Federal plan, or delegation, as applicable. For air pollution control devices...

40 CFR 60.5195 - By what date must I conduct the initial air pollution control device inspection and make any...

Code of Federal Regulations, 2012 CFR

2012-07-01

... air pollution control device inspection and make any necessary repairs? 60.5195 Section 60.5195... air pollution control device inspection and make any necessary repairs? (a) You must conduct an air... approved state plan, Federal plan, or delegation, as applicable. For air pollution control devices...

75 FR 20561 - Patent Term Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-20

... drug products, medical devices, food additives, and color additives are eligible for extension. The... approved product, or a method of manufacturing the approved product. In addition, the application for... of manufacturing a product shall be extended if the term of the patent has not expired before an...

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...

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...

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...

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...

[Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].

PubMed

Morimoto, Kazushige; Kawasaki, Satoko; Yoshida, Yasunori

2015-01-01

For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined.

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.

[Industry regulation and its relationship to the rapid marketing of medical devices].

PubMed

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

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...

Manipulation of the Phase-Amplitude Coupling Factor in Quantum Nanostructure Based Devices for On-Chip Chirp Compensation and Low-Cost Applications

DTIC Science & Technology

2014-11-17

Compensation and Low -Cost Applications Frederic Grillot CTRE NAT DE LA RECHERCHE SCIENTIFIQUE 74, RUE DE PARIS CENTRE AFFAIRES OBERTHUR RENNES, 35000...of Scientific Research European Office of Aerospace Research and Development Unit 4515, APO AE 09421-4515 Distribution Statement A: Approved for...Amplitude Coupling Factor in Quantum Nanostructure Based Devices for On-Chip Chirp Compensation and Low -Cost Applications 5a. CONTRACT NUMBER

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. Published by Elsevier Inc. All rights reserved.

Generation of Mid-Wave Infrared Signature Using Microradiating Devices for Vehicle Mounted Identification Friend or Foe Applications

DTIC Science & Technology

2009-06-01

M. Harkins Approved for public release; distribution is unlimited THIS PAGE INTENTIONALLY LEFT BLANK i REPORT DOCUMENTATION PAGE Form Approved...12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release; distribution is unlimited 12b. DISTRIBUTION CODE 13. ABSTRACT (maximum 200...The integration of a MWIR signature into VMIFF will add a daytime capability. A new generation of compact MWIR sources is emerging to meet demands

Architecture for removable media USB-ARM

DOEpatents

Shue, Craig A.; Lamb, Logan M.; Paul, Nathanael R.

2015-07-14

A storage device is coupled to a computing system comprising an operating system and application software. Access to the storage device is blocked by a kernel filter driver, except exclusive access is granted to a first anti-virus engine. The first anti-virus engine is directed to scan the storage device for malicious software and report results. Exclusive access may be granted to one or more other anti-virus engines and they may be directed to scan the storage device and report results. Approval of all or a portion of the information on the storage device is based on the results from the first anti-virus engine and the other anti-virus engines. The storage device is presented to the operating system and access is granted to the approved information. The operating system may be a Microsoft Windows operating system. The kernel filter driver and usage of anti-virus engines may be configurable by a user.

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

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

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.

Characterizing and Implementing Efficient Primitives for Privacy-Preserving Computation

DTIC Science & Technology

2015-07-01

the mobile device. From this, the mobile will detect any tampering from the malicious party by a discrepancy in these returned values, eliminating...the need for an output MAC. If no tampering is detected , the mobile device then decrypts the output of computation. APPROVED FOR PUBLIC RELEASE...useful error messages when the compiler detects a problem with an application, making debugging the application significantly easier than with other

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

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

NONE

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

75 FR 6401 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and... post this information on the Internet at http://www.fda.gov . In addition, the regulations provide that...

42 CFR 84.79 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self... respiratory tract irritating compounds. (c) Compressed, gaseous breathing air shall meet the applicable...

42 CFR 84.79 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self... respiratory tract irritating compounds. (c) Compressed, gaseous breathing air shall meet the applicable...

42 CFR 84.79 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self... respiratory tract irritating compounds. (c) Compressed, gaseous breathing air shall meet the applicable...

42 CFR 84.79 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self... respiratory tract irritating compounds. (c) Compressed, gaseous breathing air shall meet the applicable...

42 CFR 84.79 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self... respiratory tract irritating compounds. (c) Compressed, gaseous breathing air shall meet the applicable...

7 CFR 868.207 - Moisture.

Code of Federal Regulations, 2011 CFR

2011-01-01

... FOR CERTAIN AGRICULTURAL COMMODITIES United States Standards for Rough Rice Principles Governing Application of Standards § 868.207 Moisture. Water content in rough rice as determined by an approved device...

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...

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...

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...

21 CFR 814.104 - Original applications.

Code of Federal Regulations, 2014 CFR

2014-04-01

... the Center for Biologics Evaluation and Research, send this information to the Document Control Center... and Research, send this information to the Central Document Control Room, Center for Drug Evaluation... device under an approved IDE) is available to treat or diagnose the disease or condition. The application...

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.

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

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...

Rehabilitation Engineering & Assistive Technology Society (RESNA) position on the application of wheelchair standing devices: 2013 current state of the literature.

PubMed

Dicianno, Brad E; Morgan, Amy; Lieberman, Jenny; Rosen, Lauren

2016-01-01

This article, approved by the Rehabilitation Engineering & Assistive Technology Society of North America Board of Directors on December 23, 2013, shares typical clinical applications and provides evidence from the literature supporting the use of wheelchair standers.

42 CFR 84.66 - Withdrawal of applications; refund of fees.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Withdrawal of applications; refund of fees. 84.66 Section 84.66 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General...

42 CFR 84.66 - Withdrawal of applications; refund of fees.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Withdrawal of applications; refund of fees. 84.66 Section 84.66 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General...

42 CFR 84.66 - Withdrawal of applications; refund of fees.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Withdrawal of applications; refund of fees. 84.66 Section 84.66 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General...

42 CFR 84.66 - Withdrawal of applications; refund of fees.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Withdrawal of applications; refund of fees. 84.66 Section 84.66 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General...

42 CFR 84.66 - Withdrawal of applications; refund of fees.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Withdrawal of applications; refund of fees. 84.66 Section 84.66 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General...

Guidelines by the AAPM and GEC-ESTRO on the use of innovative brachytherapy devices and applications: Report of Task Group 167

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

Nath, Ravinder; Rivard, Mark J., E-mail: mark.j.rivard@gmail.com; DeWerd, Larry A.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used in the evaluation of innovative devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining the equivalence of the innovative treatment modality to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of innovative radiotherapy devices or applications is a critical part in which physicists should be actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative brachytherapy devices and applications andmore » includes evaluation of (1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, (2) risks and benefits from a regulatory and safety perspective, and (3) resource assessment and preparedness. Further, it is suggested that any developed calibration methods be traceable to a primary standards dosimetry laboratory (PSDL) such as the National Institute of Standards and Technology in the U.S. or to other PSDLs located elsewhere such as in Europe. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the Accredited Dosimetry Calibration Laboratories in the U.S. is encouraged before a source is introduced into widespread routine clinical use. The American Association of Physicists in Medicine and the Groupe Européen de Curiethérapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) have developed guidelines for the safe and consistent application of brachytherapy using innovative devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. Nuclear Regulatory Commission, U.S. Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, U.S. Food and Drug Administration, European Commission for CE Marking (Conformité Européenne), and institutional review boards and radiation safety committees.« less

MO-A-BRC-02: TG167 Report - Detailed Description

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

Rivard, M.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

MO-A-BRC-01: TG167 Report - Introduction

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

Nath, R.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

FDA's perspectives on cardiovascular devices.

PubMed

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-06-01

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

Solution Deposition Methods for Carbon Nanotube Field-Effect Transistors

DTIC Science & Technology

2009-06-01

authorized documents. Citation of manufacturer’s or trade names does not constitute an official endorsement or approval of the use thereof. Destroy...processed into FETs using standard microelectronics processing techniques. The resulting devices were characterized using a semiconductor parameter...method will help to determine which conditions are useful for producing CNT devices for chemical sensing and electronic applications. 15. SUBJECT TERMS

Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection

PubMed Central

Tummers, Willemieke S.; Warram, Jason M.; Tipirneni, Kiranya E.; Fengler, John; Jacobs, Paula; Shankar, Lalitha; Henderson, Lori; Ballard, Betsy; Pogue, Brian W.; Weichert, Jamey P.; Bouvet, Michael; Sorger, Jonathan; Contag, Christopher H.; Frangioni, John V.; Tweedle, Michael F.; Basilion, James P.; Gambhir, Sanjiv S.; Rosenthal, Eben L.

2017-01-01

Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of optical imaging, there is an urgent need to standardize surgical navigation tools and contrast agents to facilitate swift regulatory approval. Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process. This report is the result of a one-day meeting held on May 4, 2016 with officials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Surgery, and members of the World Molecular Imaging Society, which discussed consensus methods for FDA-directed human testing and approval of investigational optical imaging devices as well as contrast agents for surgical applications. The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical surgical navigation. In addition, the workshop acted to provide clarity to the research community on data collection and trial design. Reported here are the specific discussion items and recommendations from this critical and timely meeting. PMID:28428283

42 CFR 84.12 - Delivery of respirators and components by applicant; requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Delivery of respirators and components by applicant; requirements. 84.12 Section 84.12 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.12 - Delivery of respirators and components by applicant; requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Delivery of respirators and components by applicant; requirements. 84.12 Section 84.12 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.12 - Delivery of respirators and components by applicant; requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Delivery of respirators and components by applicant; requirements. 84.12 Section 84.12 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.12 - Delivery of respirators and components by applicant; requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Delivery of respirators and components by applicant; requirements. 84.12 Section 84.12 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.12 - Delivery of respirators and components by applicant; requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Delivery of respirators and components by applicant; requirements. 84.12 Section 84.12 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

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...

42 CFR 84.65 - Conduct of examinations, inspections, and tests by the Institute; assistance by applicant...

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General Construction and Performance Requirements § 84.65 Conduct of examinations, inspections, and tests by the...

Marketing approval for the lithotripter.

PubMed

Nightingale, S L; Young, F E

1986-01-01

In December 1984, the Food and Drug Administration (FDA) granted Dornier Systems (FRG) approval to market the external shock wave lithotripter (ESWL) in the USA. The Medical Device Amendments of the Food, Drug, and Cosmetic Act require that the FDA evaluate the safety and effectiveness of medical devices intended for commercial distribution in the U.S. Such evaluation includes basic scientific studies, animal testing, and investigational studies in human subjects, culminating in a judgment concerning acceptable risks in terms of anticipated benefits, and whether the device is effective for its intended use. Prior to human studies in West Germany, Dornier had evaluated the destruction of stones of varying composition, measured the rate and energy of stone destruction, and tested blood samples and lymphocyte cultures exposed to shock waves. In addition, studies in both rats and dogs had demonstrated the feasibility of the technique and evidence of safety. Such data are provided by manufacturers when applying for an investigational device exemption (IDE) from the FDA, which permits clinical studies in humans; such studies also require the approval of an Institutional Review Board. The FDA approved Dornier's IDE, allowing human investigational use of the ESWL in facilities in the U.S., conducted concurrently with similar studies in West Germany. Upon completion of clinical trials, data acquired in vitro, in laboratory animals, and in human investigations are submitted to the FDA for a premarked approval application (PMAA). The Agency was given 6 months to make a decision, taking into consideration the recommendation of an advisory panel of experts from outside the Agency who had reviewed the same data. In its evaluation of the ESWL for safety and effectiveness, the FDA considered the question of alternative practices and procedures to treat nephrolithiasis, including percutaneous nephrolithotomy and open surgical procedures, and the adverse effects of such procedures. Clinical data available at the time of review for approval included reports of treatment of 667 patients in West German centers, and 327 patients treated in three U.S. facilities. Dornier and the FDA initiated discussions concerning the labeling of the device and a postmarketing surveillance plan. These were completed and marketing approval for the ESWL was granted.

The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment.

PubMed

Goldberg, Kirsten B; Blumenthal, Gideon M; Pazdur, Richard

The Food and Drug Administration formally established the Oncology Center of Excellence (OCE) in January 2017, as authorized by the 21st Century Cures Act, to expedite the development and review of certain drugs, biologics, and devices for the treatment of cancer. In its first year, the OCE conducted the clinical reviews for several products, including the first 2 chimeric antigen receptor T-cell therapies approved for the treatment of advanced hematologic malignancies and an in vitro diagnostic next-generation sequencing panel, FoundationOne CDx. The OCE also worked with professional societies and patient advocates on efforts to modernize clinical trial eligibility criteria, resulting in recommendations regarding minimal age, brain metastases, organ dysfunction, and human immunodeficiency virus coinfection. Altogether in 2017, the Food and Drug Administration approved 16 new drug and biologic applications, 30 supplemental drug and biologic applications, and 2 biosimilar applications in oncology.

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 FDA's PMA pathway have undergone extensive revisions, including serial design and labeling changes, since their initial approvals, often without supporting clinical data. Ophthalmologists should take into consideration that cumulative revisions may render the clinical evidence that supported an original FDA approval less relevant to newer device models. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.

PubMed

Heneghan, Carl J; Goldacre, Ben; Onakpoya, Igho; Aronson, Jeffrey K; Jefferson, Tom; Pluddemann, Annette; Mahtani, Kamal R

2017-12-06

Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms. We used FDA databases to determine the evidence for approval of transvaginal mesh. To create a 'family tree' of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies. We found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1-14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes). Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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.

Regulatory approval of new medical devices: cross sectional study.

PubMed

Marcus, Hani J; Payne, Christopher J; Hughes-Hallett, Archie; Marcus, Adam P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

2016-05-20

 To investigate the regulatory approval of new medical devices.  Cross sectional study of new medical devices reported in the biomedical literature.  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

42 CFR 84.65 - Conduct of examinations, inspections, and tests by the Institute; assistance by applicant...

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General... respiratory equipment as is deemed appropriate. [60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8...

42 CFR 84.65 - Conduct of examinations, inspections, and tests by the Institute; assistance by applicant...

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General... respiratory equipment as is deemed appropriate. [60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8...

42 CFR 84.65 - Conduct of examinations, inspections, and tests by the Institute; assistance by applicant...

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General... respiratory equipment as is deemed appropriate. [60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8...

Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection.

PubMed

Tummers, Willemieke S; Warram, Jason M; Tipirneni, Kiranya E; Fengler, John; Jacobs, Paula; Shankar, Lalitha; Henderson, Lori; Ballard, Betsy; Pogue, Brian W; Weichert, Jamey P; Bouvet, Michael; Sorger, Jonathan; Contag, Christopher H; Frangioni, John V; Tweedle, Michael F; Basilion, James P; Gambhir, Sanjiv S; Rosenthal, Eben L

2017-05-01

Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of optical imaging, there is an urgent need to standardize surgical navigation tools and contrast agents to facilitate swift regulatory approval. Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process. This report is the result of a one-day meeting held on May 4, 2016 with officials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Surgery, and members of the World Molecular Imaging Society, which discussed consensus methods for FDA-directed human testing and approval of investigational optical imaging devices as well as contrast agents for surgical applications. The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical surgical navigation. In addition, the workshop acted to provide clarity to the research community on data collection and trial design. Reported here are the specific discussion items and recommendations from this critical and timely meeting. Cancer Res; 77(9); 2197-206. ©2017 AACR . ©2017 American Association for Cancer Research.

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.

Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

PubMed

Chambers, James D; May, Katherine E; Neumann, Peter J

2013-06-01

The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

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.

30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...

76 FR 48563 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2011...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...-7205 Ventricular Assist Device (Destination Therapy) Facilities. XIII Medicare-Approved Lung JoAnna...-Approved Ventricular Assist Device (Destination Therapy) Facilities, Addendum XIII: Lung Volume Reduction...-Approved Ventricular Assist Device (Destination Therapy) Facilities (January Through March 2011) Addendum...

20 CFR 655.720 - Where are labor condition applications (LCAs) to be filed and processed?

Code of Federal Regulations, 2010 CFR

2010-04-01

...' statements or invoices for medical devices or aids relevant to the employer's disability. (4) ETA may approve... Occupations and as Fashion Models, and Requirements for Employers Seeking To Employ Nonimmigrants on H-1b1 and...

20 CFR 655.720 - Where are labor condition applications (LCAs) to be filed and processed?

Code of Federal Regulations, 2011 CFR

2011-04-01

...' statements or invoices for medical devices or aids relevant to the employer's disability. (4) ETA may approve... Occupations and as Fashion Models, and Requirements for Employers Seeking To Employ Nonimmigrants on H-1b1 and...

14 CFR 121.917 - Other requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... technical (piloting or other) skills in an actual or simulated operations scenario. For flight crewmembers this training and evaluation must be conducted in an approved flight training device, flight simulator... Dispatcher Resource Management (DRM) ground and if appropriate flight training applicable to each position...

14 CFR 121.917 - Other requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... technical (piloting or other) skills in an actual or simulated operations scenario. For flight crewmembers this training and evaluation must be conducted in an approved flight training device, flight simulator... Dispatcher Resource Management (DRM) ground and if appropriate flight training applicable to each position...

14 CFR 121.917 - Other requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... technical (piloting or other) skills in an actual or simulated operations scenario. For flight crewmembers this training and evaluation must be conducted in an approved flight training device, flight simulator... Dispatcher Resource Management (DRM) ground and if appropriate flight training applicable to each position...

14 CFR 121.917 - Other requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... technical (piloting or other) skills in an actual or simulated operations scenario. For flight crewmembers this training and evaluation must be conducted in an approved flight training device, flight simulator... Dispatcher Resource Management (DRM) ground and if appropriate flight training applicable to each position...

49 CFR 235.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SIGNAL SYSTEM OR RELIEF FROM THE REQUIREMENTS OF PART 236 § 235.1 Scope. This part prescribes application for approval to discontinue or materially modify block signal systems, interlockings, traffic control systems, automatic train stop, train control, or cab signal systems, or other similar appliances, devices...

76 FR 69321 - Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche AGENCY: National Highway Traffic Safety... previously approved antitheft device. SUMMARY: On May 25, 1989, the National Highway Traffic Safety...

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.

30 CFR 90.205 - Approved sampling devices; operation; air flowrate.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...

30 CFR 75.1107-13 - Approval of other fire suppression devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-13 Approval of... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of other fire suppression devices. 75...

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.

9 CFR 312.2 - Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or...

Code of Federal Regulations, 2010 CFR

2010-01-01

... livers, beef tongues, beef hearts, and smoked meats not in casings. EC11SE91.003 For application to... on shipping containers, band labels, artificial casings, and other articles with the approval of the...

30 CFR 7.45 - Critical characteristics

Code of Federal Regulations, 2014 CFR

2014-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.45 Critical characteristics The following critical characteristics shall be inspected or tested on each battery assembly to... terminations. (e) Strain relief devices for cables leaving boxes. (f) Type, location, and physical protection...

30 CFR 7.45 - Critical characteristics

Code of Federal Regulations, 2013 CFR

2013-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.45 Critical characteristics The following critical characteristics shall be inspected or tested on each battery assembly to... terminations. (e) Strain relief devices for cables leaving boxes. (f) Type, location, and physical protection...

30 CFR 7.45 - Critical characteristics

Code of Federal Regulations, 2010 CFR

2010-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.45 Critical characteristics The following critical characteristics shall be inspected or tested on each battery assembly to... terminations. (e) Strain relief devices for cables leaving boxes. (f) Type, location, and physical protection...

14 CFR 125.297 - Approval of flight simulators and flight training devices.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., testing, and checking required by this subpart. (b) Each flight simulator and flight training device that... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a...

14 CFR 125.297 - Approval of flight simulators and flight training devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., testing, and checking required by this subpart. (b) Each flight simulator and flight training device that... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a...

14 CFR 125.297 - Approval of flight simulators and flight training devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., testing, and checking required by this subpart. (b) Each flight simulator and flight training device that... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a...

14 CFR 125.297 - Approval of flight simulators and flight training devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., testing, and checking required by this subpart. (b) Each flight simulator and flight training device that... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a...

14 CFR 125.297 - Approval of flight simulators and flight training devices.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., testing, and checking required by this subpart. (b) Each flight simulator and flight training device that... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a...

[Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].

PubMed

Renisch, B; Lauer, W

2014-12-01

An integral part of the conformity assessment process for medical devices is a clinical evaluation based on clinical data. Particularly in the case of implantable devices and products of risk class III clinical trials must be performed. Since March 2010 applications for the authorization of clinical trials as well as for the waiver of the authorization requirement must be submitted centrally in Germany to the appropriate federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). In addition to authorization, approval by the responsible ethics committee is also required under law in order to begin clinical testing of medical devices in Germany. In this paper, the legal framework for the clinical testing of medical devices as well as those involved and possible procedures including evaluation criteria for the initial application of a trial and subsequent amendments are presented in detail. In addition, the reporting requirements for serious adverse events (SAEs) are explained and possible consequences of the evaluation are presented. Finally, a summary of application and registration numbers for all areas of extensive experience of the BfArM as well as requests and guidance for applicants are presented.

14 CFR 63.39 - Skill requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... simulator, or in an approved flight engineer training device, show that he can satisfactorily perform... CERTIFICATION: FLIGHT CREWMEMBERS OTHER THAN PILOTS Flight Engineers § 63.39 Skill requirements. (a) An applicant for a flight engineer certificate with a class rating must pass a practical test on the duties of...

14 CFR 63.39 - Skill requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... simulator, or in an approved flight engineer training device, show that he can satisfactorily perform... CERTIFICATION: FLIGHT CREWMEMBERS OTHER THAN PILOTS Flight Engineers § 63.39 Skill requirements. (a) An applicant for a flight engineer certificate with a class rating must pass a practical test on the duties of...

An Operational Safety and Certification Assessment of a TASAR EFB Application

NASA Technical Reports Server (NTRS)

Koczo, Stefan; Wing, David

2013-01-01

This paper presents an overview of a Traffic Aware Strategic Aircrew Requests (TASAR) Electronic Flight Bag application intended to inform the pilot of trajectory improvement opportunities while en route that result in operational benefits. The results of safety analyses and a detailed review of Federal Aviation Administration (FAA) regulatory documents that establish certification and operational approval requirements are presented for TASAR. The safety analyses indicate that TASAR has a likely Failure Effects Classification of “No Effect,” and at most, is no worse than “Minor Effect.” Based on this safety assessment and the detailed review of FAA regulatory documents that determine certification and operational approval requirements, this study concludes that TASAR can be implemented in the flight deck as a Type B software application hosted on a Class 2 Portable Electronic Device (PED) Electronic Flight Bag (EFB). This implementation approach would provide a relatively low-cost path to certification and operational approval for both retrofit and forward fit implementation, while at the same time facilitating the business case for early ADS-B IN equipage. A preliminary review by FAA certification and operational approvers of the analyses presented here confirmed that the conclusions are appropriate and that TASAR will be considered a Type B application.

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

PubMed Central

Beaver, Julia A.; Tzou, Abraham; Blumenthal, Gideon M.; McKee, Amy E.; Kim, Geoffrey; Pazdur, Richard; Philip, Reena

2016-01-01

As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this article, we will describe the potential benefit of complex signatures and their unique regulatory challenges including analytical performance validation, complex signature simulation, and clinical performance evaluation. We also will review the potential regulatory pathways for clearance, approval, or acceptance of complex signatures by the U.S. Food and Drug Administration (FDA). These regulatory pathways include regulations applicable to in vitro diagnostic devices, including companion diagnostic devices, the potential for labeling as a complementary diagnostic, and the biomarker qualification program. PMID:27993967

14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. (a) Each airplane simulator and other training device that is used in a training course permitted under § 121.409...

14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. (a) Each airplane simulator and other training device that is used in a training course permitted under § 121.409...

14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. (a) Each airplane simulator and other training device that is used in a training course permitted under § 121.409...

14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. Link to an amendment published at 78 FR 67836, Nov. 12, 2013. (a) Each airplane simulator and other training device...

14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. (a) Each airplane simulator and other training device that is used in a training course permitted under § 121.409...

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 814.47 - 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...

Statistical inference for the within-device precision of quantitative measurements in assay validation.

PubMed

Liu, Jen-Pei; Lu, Li-Tien; Liao, C T

2009-09-01

Intermediate precision is one of the most important characteristics for evaluation of precision in assay validation. The current methods for evaluation of within-device precision recommended by the Clinical Laboratory Standard Institute (CLSI) guideline EP5-A2 are based on the point estimator. On the other hand, in addition to point estimators, confidence intervals can provide a range for the within-device precision with a probability statement. Therefore, we suggest a confidence interval approach for assessment of the within-device precision. Furthermore, under the two-stage nested random-effects model recommended by the approved CLSI guideline EP5-A2, in addition to the current Satterthwaite's approximation and the modified large sample (MLS) methods, we apply the technique of generalized pivotal quantities (GPQ) to derive the confidence interval for the within-device precision. The data from the approved CLSI guideline EP5-A2 illustrate the applications of the confidence interval approach and comparison of results between the three methods. Results of a simulation study on the coverage probability and expected length of the three methods are reported. The proposed method of the GPQ-based confidence intervals is also extended to consider the between-laboratories variation for precision assessment.

42 CFR 84.141 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air...) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or...

42 CFR 84.141 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air...) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or...

42 CFR 84.141 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air...) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or...

42 CFR 84.141 - Breathing gas; minimum requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air...) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or...

76 FR 47143 - Approval for Manufacturing Authority, Foreign-Trade Zone 153; Abbott Cardiovascular Systems, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... Authority, Foreign-Trade Zone 153; Abbott Cardiovascular Systems, Inc., (Cardiovascular Devices), Riverside... of Abbott Cardiovascular Systems, Inc., within Sites 11-13 of FTZ 153, located in Riverside County... behalf of Abbott Cardiovascular Systems, Inc., as described in the application and Federal Register...

10 CFR 70.23 - Requirements for the approval of applications.

Code of Federal Regulations, 2010 CFR

2010-01-01

... be used for the conduct of research or development activities of a type specified in section 31 of... types of research and development activities specified in section 31 are those relating to: (1) Nuclear processes; (2) The theory and production of atomic energy, including processes, materials, and devices...

The Regulatory Perspectives on Endoscopic Devices for Obesity.

PubMed

Marrone, April K; Antonino, Mark J; Silverstein, Joshua S; Betz, Martha W; Venkataraman-Rao, Priya; Golding, Martin; Cordray, Diane; Cooper, Jeffrey W

2017-04-01

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study. Published by Elsevier Inc.

Annual update: drugs, diagnostics and devices.

PubMed

Berardinelli, Candace; Kupecz, Deborah

2003-03-01

As NPs continue to play an important role in health care as administers of prescriptions, the value of reviewing the latest Food and Drug Administration (FDA) approvals for new drugs and devices is immeasurable. In 2002, the FDA approved several new drugs and devices, as well as monitored previously approved drugs for adverse reactions and untoward events. This article provides a brief review of relevant primary care topics.

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 814.46 - 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 814.46 - 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...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

75 FR 26941 - Information Collection; Submission for OMB Review, Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... Development, and Training grants to the Office of Management and Budget (OMB) for review and approval in... telecommunications device for the deaf (TTY-TDD) may call (202) 565-2799 between 8:30 a.m. and 5 p.m. eastern time... AmeriCorps Application Instructions: Administrative, Program Development, and Training grants. State...

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...

[Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

PubMed

Niimi, Shingo

2015-01-01

Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

14 CFR 142.63 - Privileges.

Code of Federal Regulations, 2010 CFR

2010-01-01

... may allow flight simulator instructors and evaluators to meet recency of experience requirements through the use of a qualified and approved flight simulator or qualified and approved flight training device if that flight simulator or flight training device is— (a) Used in a course approved in accordance...

14 CFR 142.63 - Privileges.

Code of Federal Regulations, 2013 CFR

2013-01-01

... may allow flight simulator instructors and evaluators to meet recency of experience requirements through the use of a qualified and approved flight simulator or qualified and approved flight training device if that flight simulator or flight training device is— (a) Used in a course approved in accordance...

14 CFR 142.63 - Privileges.

Code of Federal Regulations, 2014 CFR

2014-01-01

... may allow flight simulator instructors and evaluators to meet recency of experience requirements through the use of a qualified and approved flight simulator or qualified and approved flight training device if that flight simulator or flight training device is— (a) Used in a course approved in accordance...

14 CFR 142.63 - Privileges.

Code of Federal Regulations, 2011 CFR

2011-01-01

... may allow flight simulator instructors and evaluators to meet recency of experience requirements through the use of a qualified and approved flight simulator or qualified and approved flight training device if that flight simulator or flight training device is— (a) Used in a course approved in accordance...

14 CFR 142.63 - Privileges.

Code of Federal Regulations, 2012 CFR

2012-01-01

... may allow flight simulator instructors and evaluators to meet recency of experience requirements through the use of a qualified and approved flight simulator or qualified and approved flight training device if that flight simulator or flight training device is— (a) Used in a course approved in accordance...

75 FR 875 - Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-06

... imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to..., for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. Further, the...] Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and...

14 CFR 61.4 - Qualification and approval of flight simulators and flight training devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... for certain flight training devices. (b) Any device used for flight training, testing, or checking... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Qualification and approval of flight simulators and flight training devices. 61.4 Section 61.4 Aeronautics and Space FEDERAL AVIATION...

14 CFR 61.4 - Qualification and approval of flight simulators and flight training devices.

Code of Federal Regulations, 2013 CFR

2013-01-01

... for certain flight training devices. (b) Any device used for flight training, testing, or checking... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Qualification and approval of flight simulators and flight training devices. 61.4 Section 61.4 Aeronautics and Space FEDERAL AVIATION...

14 CFR 61.4 - Qualification and approval of flight simulators and flight training devices.

Code of Federal Regulations, 2012 CFR

2012-01-01

... for certain flight training devices. (b) Any device used for flight training, testing, or checking... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Qualification and approval of flight simulators and flight training devices. 61.4 Section 61.4 Aeronautics and Space FEDERAL AVIATION...

14 CFR 61.4 - Qualification and approval of flight simulators and flight training devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... for certain flight training devices. (b) Any device used for flight training, testing, or checking... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Qualification and approval of flight simulators and flight training devices. 61.4 Section 61.4 Aeronautics and Space FEDERAL AVIATION...

14 CFR 61.4 - Qualification and approval of flight simulators and flight training devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... for certain flight training devices. (b) Any device used for flight training, testing, or checking... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Qualification and approval of flight simulators and flight training devices. 61.4 Section 61.4 Aeronautics and Space FEDERAL AVIATION...

"Off Label" Use of FDA-Approved Devices and Digital Breast Tomosynthesis.

PubMed

Kopans, Daniel B

2015-11-01

The purpose of this article is to clarify for radiologists the meaning of U.S. Food and Drug Administration (FDA) approval with respect to Digital Breast Tomosynthesis (DBT). DBT is a major improvement over 2D mammography in the detection of cancers (sensitivity) and the reduction in recalls resulting from screening (specificity). Most imaging systems that have been approved by the FDA are used "off label" for breast imaging. Although the FDA determines which claims a manufacturer can make for a device, physicians may use approved devices, such as DBT, off label to provide better patient care.

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 ...

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Specific requirements for approval. 23.7...

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Specific requirements for approval. 23.7...

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Specific requirements for approval. 23.7...

Database Creation and Statistical Analysis: Finding Connections Between Two or More Secondary Storage Device

DTIC Science & Technology

2017-09-01

NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS DATABASE CREATION AND STATISTICAL ANALYSIS: FINDING CONNECTIONS BETWEEN TWO OR MORE SECONDARY...BLANK ii Approved for public release. Distribution is unlimited. DATABASE CREATION AND STATISTICAL ANALYSIS: FINDING CONNECTIONS BETWEEN TWO OR MORE...Problem and Motivation . . . . . . . . . . . . . . . . . . . 1 1.2 DOD Applicability . . . . . . . . . . . . . . . . .. . . . . . . 2 1.3 Research

77 FR 40701 - Notification of Petition for Approval; Informational Filing and Request for Waiver

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... of the work requires UP to design procure and install: 1. Cab signal fixed equipment in an initial... warning devices by passenger trains operating in excess of 79 mph. In addition, the two-way communications...; Section 235.5, Changes requiring filing of application; Section 240.127, Criteria for examining skill...

42 CFR 84.60 - Construction and performance requirements; general.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... Institute shall issue approvals for other respiratory protective devices not specifically described in this...

42 CFR 84.60 - Construction and performance requirements; general.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... Institute shall issue approvals for other respiratory protective devices not specifically described in this...

42 CFR 84.60 - Construction and performance requirements; general.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... Institute shall issue approvals for other respiratory protective devices not specifically described in this...

42 CFR 84.60 - Construction and performance requirements; general.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... Institute shall issue approvals for other respiratory protective devices not specifically described in this...

42 CFR 84.60 - Construction and performance requirements; general.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... Institute shall issue approvals for other respiratory protective devices not specifically described in this...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

21 CFR 812.42 - FDA and IRB approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

Audio-based queries for video retrieval over Java enabled mobile devices

NASA Astrophysics Data System (ADS)

Ahmad, Iftikhar; Cheikh, Faouzi Alaya; Kiranyaz, Serkan; Gabbouj, Moncef

2006-02-01

In this paper we propose a generic framework for efficient retrieval of audiovisual media based on its audio content. This framework is implemented in a client-server architecture where the client application is developed in Java to be platform independent whereas the server application is implemented for the PC platform. The client application adapts to the characteristics of the mobile device where it runs such as screen size and commands. The entire framework is designed to take advantage of the high-level segmentation and classification of audio content to improve speed and accuracy of audio-based media retrieval. Therefore, the primary objective of this framework is to provide an adaptive basis for performing efficient video retrieval operations based on the audio content and types (i.e. speech, music, fuzzy and silence). Experimental results approve that such an audio based video retrieval scheme can be used from mobile devices to search and retrieve video clips efficiently over wireless networks.

30 CFR 57.22227 - Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines). 57.22227 Section 57.22227 Mineral Resources MINE SAFETY AND... Ventilation § 57.22227 Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines). (a...

US FDA perspective on regulatory issues affecting circulatory assist devices.

PubMed

Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram

2006-11-01

There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.

30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests; approved devices. Tests for oxygen deficiency shall be made with a permissible flame safety lamp or other...

30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests; approved devices. Tests for oxygen deficiency shall be made with a permissible flame safety lamp or other...

30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests; approved devices. Tests for oxygen deficiency shall be made with a permissible flame safety lamp or other...

30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests; approved devices. Tests for oxygen deficiency shall be made with a permissible flame safety lamp or other...

76 FR 50663 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... completion of a PDP is not filed by the latter of the two dates, and no IDE is in effect, the device is... availability of a preamendments class III devices strategy document. The strategy document set forth FDA's... approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180...

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

PubMed

Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

2017-08-15

High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved.

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.

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.

Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration

PubMed Central

Herz, Naomi; Loyo-Berrios, Nilsa; Tarver, Michelle

2014-01-01

Abstract Background: Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS). Methods: The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex. Results: Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants. Conclusions: Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat. PMID:24405314

[Requirements for drug approval and additional benefits assessment: Regulatory aspects and experiences].

PubMed

Broich, K; Löbker, W; Schulte, A; Beinlich, P; Müller, T

2016-04-01

The early assessment of benefits of newly approved drugs with novel active substances or new applications, which came into force on 1 January 2011 still represents a challenge to all parties involved. This article highlights the definitions, regulatory requirements and interaction between drug marketing approval and early assessment of benefits in Germany. The constellation of an extensively harmonized European and even international drug authorization process with a predominantly national regulation of drug reimbursement situation inevitably causes friction, which could be markedly reduced through early joint advisory discussions during the planning phase for pivotal clinical trials. During the year 2015 the Federal Institute for Drugs and Medical Devices (BfArM) carried out 300 scientific advice procedures of which 34 were concerned with applications in the field of indications for the central nervous system (CNS). In comparison 98 advisory meetings were held by the Federal Joint Committee (G-BA) of which the BfArM provided advice in 12 instances and in 2 cases on CNS indications. Study design, endpoints and appropriate comparative therapies are the key issues in exchanges and discussions between the BfArM, the G‑BA and applicants. Under these aspects the BfArM and G‑BA promote an early and consistent involvement in early advice procedures regarding the prerequisites for drug approval and assessment of additional benefits.

9 CFR 312.2 - Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or...

Code of Federal Regulations, 2014 CFR

2014-01-01

... Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY... goats, meat food products in animal casings, and other products as approved by the Administrator, shall... lieu thereof. EC11SE91.000 For application to sheep carcasses, the loins and ribs of pork, beef tails...

9 CFR 312.2 - Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or...

Code of Federal Regulations, 2013 CFR

2013-01-01

... Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY... goats, meat food products in animal casings, and other products as approved by the Administrator, shall... lieu thereof. EC11SE91.000 For application to sheep carcasses, the loins and ribs of pork, beef tails...

9 CFR 312.2 - Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or...

Code of Federal Regulations, 2011 CFR

2011-01-01

... Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY... goats, meat food products in animal casings, and other products as approved by the Administrator, shall... lieu thereof. EC11SE91.000 For application to sheep carcasses, the loins and ribs of pork, beef tails...

9 CFR 312.2 - Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or...

Code of Federal Regulations, 2012 CFR

2012-01-01

... Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY... goats, meat food products in animal casings, and other products as approved by the Administrator, shall... lieu thereof. EC11SE91.000 For application to sheep carcasses, the loins and ribs of pork, beef tails...

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.

Development of a Device for Objective Assessment of Tinnitus in Humans

DTIC Science & Technology

2017-10-01

develop and refine the Gap Device and testing methodology . In the third year of the grant, we began to conduct a multisite research study to...in the last quarter of 2016. Secured IRB approvals for all study sites (SIU, Portland VA, Madigan Army Medical Center). HRPO approvals obtained for all... study sites. IRB Continuing Review (CR) and HRPO CR approvals also obtained for SIU and PVA. MAMC IRB CR and HRPO CR approvals are not due until

30 CFR 75.1107-3 - Fire suppression devices; approved components; installation requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-3... agency approved by the Secretary. (b) Where used, pressure vessels shall conform with the requirements of...

30 CFR 75.1107-3 - Fire suppression devices; approved components; installation requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-3... agency approved by the Secretary. (b) Where used, pressure vessels shall conform with the requirements of...

30 CFR 75.1107-3 - Fire suppression devices; approved components; installation requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-3... agency approved by the Secretary. (b) Where used, pressure vessels shall conform with the requirements of...

30 CFR 75.1107-3 - Fire suppression devices; approved components; installation requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-3... agency approved by the Secretary. (b) Where used, pressure vessels shall conform with the requirements of...

30 CFR 75.1107-3 - Fire suppression devices; approved components; installation requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-3... agency approved by the Secretary. (b) Where used, pressure vessels shall conform with the requirements of...

Update on the status of infrarenal AAA devices.

PubMed

Hart, Theodore; Milner, Ross

2018-06-01

There are a variety of endografts currently available for endovascular repair of abdominal aortic aneurysms. Aneurysms of increasing anatomic complexity are being repaired with devices that are either newly approved or redesigned relative to the initial published experience with infrarenal endovascular aortic aneurysm repair (EVAR). This article describes the contemporary devices approved for infrarenal EVAR in the United States and includes an up-to-date compilation of the data addressing outcomes specific to each device.

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

Demystifying the U.S. Food and Drug Administration: I. Understanding agency structure and function.

PubMed

Levi, Benjamin; Lisiecki, Jeffrey; Rubin, Peter; D'Amico, Richard A; Hume, Keith M; Seward, Bill; Cederna, Paul S

2014-06-01

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided.

Intradermal vaccination using the novel microneedle device MicronJet600: Past, present, and future.

PubMed

Levin, Yotam; Kochba, Efrat; Hung, Ivan; Kenney, Richard

2015-01-01

Intradermal immunization has become a forefront of vaccine improvement, both scientifically and commercially. Newer technologies are being developed to address the need to reduce the dose required for vaccination and to improve the reliability and ease of injection, which have been major hurdles in expanding the number of approved vaccines using this route of administration. In this review, 7 y of clinical experience with a novel intradermal delivery device, the MicronJet600, which is a registered hollow microneedle that simplifies the delivery of liquid vaccines, are summarized. This device has demonstrated both significant dose-sparing and superior immunogenicity in various vaccine categories, as well as in diverse subject populations and age groups. These studies have shown that intradermal delivery using this device is safe, effective, and preferred by the subjects. Comparison with other intradermal devices and potential new applications for intradermal delivery that could be pursued in the future are also discussed.

Medical Device Regulation: A Comparison of the United States and the European Union.

PubMed

Maak, Travis G; Wylie, James D

2016-08-01

Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.

California; Northern Sierra Air Quality Management District; Approval of Air Plan Revisions; Wood Burning Devices

EPA Pesticide Factsheets

EPA is taking final action to approve a revision to the Northern Sierra Air Quality Management District (NSAQMD) portion of the California SIP concerning emissions of particulate matter (PM) from wood burning devices.

Neurostimulation for Drug-Resistant Epilepsy

PubMed Central

DeGiorgio, Christopher M.; Krahl, Scott E.

2013-01-01

Purpose of Review: The purpose of this review is to provide an evidence-based update on the neurostimulation options available for patients with drug-resistant epilepsy in the United States and in European countries. Recent Findings: The field of neurostimulation for epilepsy has grown dramatically since 1997, when vagus nerve stimulation became the first device to be approved for epilepsy by the US Food and Drug Administration (FDA). New data from recently completed randomized controlled trials are available for deep brain stimulation of the anterior thalamus, responsive neurostimulation, and trigeminal nerve stimulation. Although vagus nerve stimulation is the only device currently approved in the United States, deep brain stimulation and responsive neurostimulation devices are awaiting FDA approval. Deep brain stimulation, trigeminal nerve stimulation, and transcutaneous vagus nerve stimulation are now approved for epilepsy in the European Union. In this article, the mechanisms of action, safety, and efficacy of new neurostimulation devices are reviewed, and the key advantages and disadvantages of each are discussed. Summary: The exponential growth of the field of neuromodulation for epilepsy is an exciting development; these new devices provide physicians with new options for patients with drug-resistant epilepsy. PMID:23739108

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/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively. Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.

Color Vision Changes and Effects of High Contrast Visor Use at Simulated Cabin Altitudes

DTIC Science & Technology

2016-06-08

under these conditions. Following Institutional Review Board approval, a reduced oxygen breathing device was used to expose subjects with normal...vision, high contrast visor, reduced oxygen breathing device 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT SAR 18. NUMBER OF...in further degradation of color vision under these conditions. Following Institutional Review Board approval, a reduced oxygen breathing device was

78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-25

... approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a... approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a... fulfilled in order for a sponsor to utilize the migration study approach in support of the change. The FDA...

Safety and Efficacy of the BrainPort V100 Device in Individuals Blinded by Traumatic Injury

DTIC Science & Technology

2016-12-01

the functional performance of the BrainPort® V200 device, a non-surgical, FDA approved, sensory substitution system, in persons who are profoundly...The BrainPort V200 device is a wearable, non-surgical, FDA approved, prosthetic device intended for people who are profoundly blind. The BrainPort...BrainPort V200 electronic vision aid (described previously) has been developed under this research. FDA clearance to market the V200 in the US is expected

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

PubMed Central

Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E

2015-01-01

Pragmatic clinical trials (PCTs) can help answer questions of comparative effectiveness for interventions routinely used in medical practice. PCTs may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration (FDA) is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity upon which approval of medical products are made. The FDA has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable FDA regulations. While many PCTs will meet the criteria for an exemption from the requirements for an investigational new drug application (IND) or investigational device exemption (IDE), in general all clinical investigations of medical products that fall under FDA jurisdiction must adhere to regulations for informed consent and review by an institutional review board (IRB). We are concerned that current FDA requirements for obtaining individual informed consent may deter or delay the conduct of PCTs intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the FDA. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk PCTs. We recommend that the FDA establish a risk-based approach to obtaining informed consent in PCTs that would facilitate the conduct of PCTs without compromising the protection of enrolled individuals or the integrity of the resulting data. PMID:26374684

30 CFR 71.100 - Respirable dust standard.

Code of Federal Regulations, 2010 CFR

2010-07-01

... concentration of respirable dust in the mine atmosphere during each shift to which each miner in the active... shall be measured with an approved sampling device and expressed in terms of an equivalent concentration determined in accordance with § 71.206 (Approved sampling devices; equivalent concentrations). ...

46 CFR 117.72 - Personal flotation devices carried in addition to life jackets.

Code of Federal Regulations, 2014 CFR

2014-10-01

... devices that include “ski vests,” “boating vests,” and “fishing vests,” approved in accordance with § 160... additional equipment. (c) Buoyant work vests approved in accordance with § 160.053 in subchapter Q of this...

46 CFR 117.72 - Personal flotation devices carried in addition to life jackets.

Code of Federal Regulations, 2013 CFR

2013-10-01

... devices that include “ski vests,” “boating vests,” and “fishing vests,” approved in accordance with § 160... additional equipment. (c) Buoyant work vests approved in accordance with § 160.053 in subchapter Q of this...

46 CFR 117.72 - Personal flotation devices carried in addition to life jackets.

Code of Federal Regulations, 2012 CFR

2012-10-01

... devices that include “ski vests,” “boating vests,” and “fishing vests,” approved in accordance with § 160... additional equipment. (c) Buoyant work vests approved in accordance with § 160.053 in subchapter Q of this...

46 CFR 161.012-11 - Approval tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Approval tests. 161.012-11 Section 161.012-11 Shipping...: SPECIFICATIONS AND APPROVAL ELECTRICAL EQUIPMENT Personal Flotation Device Lights § 161.012-11 Approval tests. (a) The approval tests described in this section must be conducted for each light submitted for Coast...

46 CFR 161.012-11 - Approval tests.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Approval tests. 161.012-11 Section 161.012-11 Shipping...: SPECIFICATIONS AND APPROVAL ELECTRICAL EQUIPMENT Personal Flotation Device Lights § 161.012-11 Approval tests. (a) The approval tests described in this section must be conducted for each light submitted for Coast...

Risk management and regulations for lower limb medical exoskeletons: a review

PubMed Central

He, Yongtian; Eguren, David; Luu, Trieu Phat; Contreras-Vidal, Jose L

2017-01-01

Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human-machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals with gait disabilities to safely and independently ambulate. PMID:28533700

[Study on the reform and improvement of the medical device registration system in China].

PubMed

Wang, Lanming

2012-11-01

Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.

Fundamental Properties and Practical Application of Active Microwave Metamaterials Incorporating Gain Devices

DTIC Science & Technology

2017-02-22

AFOSR)/ RTB1 Arlington, Virginia 22203 Air Force Research Laboratory Air Force Materiel Command REPORT DOCUMENTATION PAGE Form ApprovedOMB No . 0704...Department of Defense, Executive Services, Directorate (0704-0188).   Respondents should be aware that notwithstanding any other provision of law, no ...mainly due to the intrinsic loss and narrow bandwidth (large dispersion) determined by the fundamental physics of metamaterials. In this program, we

Comparison of Six Different Silicones In Vitro for Application as Glaucoma Drainage Device

PubMed Central

Windhövel, Claudia; Harder, Lisa; Bach, Jan-Peter; Teske, Michael; Grabow, Niels; Eickner, Thomas; Chichkov, Boris; Nolte, Ingo

2018-01-01

Silicones are widely used in medical applications. In ophthalmology, glaucoma drainage devices are utilized if conservative therapies are not applicable or have failed. Long-term success of these devices is limited by failure to control intraocular pressure due to fibrous encapsulation. Therefore, different medical approved silicones were tested in vitro for cell adhesion, cell proliferation and viability of human Sclera (hSF) and human Tenon fibroblasts (hTF). The silicones were analysed also depending on the sample preparation according to the manufacturer’s instructions. The surface quality was characterized with environmental scanning electron microscope (ESEM) and water contact angle measurements. All silicones showed homogeneous smooth and hydrophobic surfaces. Cell adhesion was significantly reduced on all silicones compared to the negative control. Proliferation index and cell viability were not influenced much. For development of a new glaucoma drainage device, the silicones Silbione LSR 4330 and Silbione LSR 4350, in this study, with low cell counts for hTF and low proliferation indices for hSF, and silicone Silastic MDX4-4210, with low cell counts for hSF and low proliferation indices for hTF, have shown the best results in vitro. Due to the high cell adhesion shown on Silicone LSR 40, 40,026, this material is unsuitable. PMID:29495462

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...

78 FR 37546 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

... ``Administrative Detention and Banned Medical Devices'' has been approved by the Office of Management and Budget...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Detention and Banned Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

75 FR 24708 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-05

... ``Administrative Detention and Banned Medical Devices'' has been approved by the Office of Management and Budget...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Detention and Banned Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

78 FR 76840 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval... ``Unique Device Identification System'' has been approved by the Office of Management and Budget (OMB... information entitled ``Unique Device Identification System'' to OMB for review and clearance under 44 U.S.C...

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...

FDA Approvals - Cancer Currents Blog

Cancer.gov

Blog posts on cancer drugs and devices approved by the Food and Drug Administration—including summaries of the evidence to support the approvals and what they mean for patients—from NCI Cancer Currents.

3D printing of a wearable personalized oral delivery device: A first-in-human study

PubMed Central

Brambilla, Davide

2018-01-01

Despite the burgeoning interest in three-dimensional (3D) printing for the manufacture of customizable oral dosage formulations, a U.S. Food and Drug Administration–approved tablet notwithstanding, the full potential of 3D printing in pharmaceutical sciences has not been realized. In particular, 3D-printed drug-eluting devices offer the possibility for personalization in terms of shape, size, and architecture, but their clinical applications have remained relatively unexplored. We used 3D printing to manufacture a tailored oral drug delivery device with customizable design and tunable release rates in the form of a mouthguard and, subsequently, evaluated the performance of this system in the native setting in a first-in-human study. Our proof-of-concept work demonstrates the immense potential of 3D printing as a platform for the development and translation of next-generation drug delivery devices for personalized therapy. PMID:29750201

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

PubMed Central

Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.

2012-01-01

Background Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting. Please see later in the article for the Editors' Summary. PMID:22912563

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...

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...

30 CFR 77.201-1 - Tests for methane; qualified person; use of approved device.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Tests for methane; qualified person; use of... WORK AREAS OF UNDERGROUND COAL MINES Surface Installations § 77.201-1 Tests for methane; qualified person; use of approved device. Tests for methane in structures, enclosures, or other facilities, in...

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 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...

9 CFR 381.137 - Evidence of labeling and devices approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Evidence of labeling and devices approval. 381.137 Section 381.137 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION...

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...

30 CFR 77.201-1 - Tests for methane; qualified person; use of approved device.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Tests for methane; qualified person; use of... WORK AREAS OF UNDERGROUND COAL MINES Surface Installations § 77.201-1 Tests for methane; qualified person; use of approved device. Tests for methane in structures, enclosures, or other facilities, in...

42 CFR 84.31 - Certificates of approval; contents.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Certificates of approval; contents. 84.31 Section 84.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.31 - Certificates of approval; contents.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Certificates of approval; contents. 84.31 Section 84.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.31 - Certificates of approval; contents.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Certificates of approval; contents. 84.31 Section 84.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.31 - Certificates of approval; contents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Certificates of approval; contents. 84.31 Section 84.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.31 - Certificates of approval; contents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Certificates of approval; contents. 84.31 Section 84.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

Intradermal vaccination using the novel microneedle device MicronJet600: Past, present, and future

PubMed Central

Levin, Yotam; Kochba, Efrat; Hung, Ivan; Kenney, Richard

2015-01-01

Intradermal immunization has become a forefront of vaccine improvement, both scientifically and commercially. Newer technologies are being developed to address the need to reduce the dose required for vaccination and to improve the reliability and ease of injection, which have been major hurdles in expanding the number of approved vaccines using this route of administration. In this review, 7 y of clinical experience with a novel intradermal delivery device, the MicronJet600, which is a registered hollow microneedle that simplifies the delivery of liquid vaccines, are summarized. This device has demonstrated both significant dose-sparing and superior immunogenicity in various vaccine categories, as well as in diverse subject populations and age groups. These studies have shown that intradermal delivery using this device is safe, effective, and preferred by the subjects. Comparison with other intradermal devices and potential new applications for intradermal delivery that could be pursued in the future are also discussed. PMID:25745830

42 CFR 84.34 - Revocation of certificates of approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Revocation of certificates of approval. 84.34 Section 84.34 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.34 - Revocation of certificates of approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Revocation of certificates of approval. 84.34 Section 84.34 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.34 - Revocation of certificates of approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Revocation of certificates of approval. 84.34 Section 84.34 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.34 - Revocation of certificates of approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Revocation of certificates of approval. 84.34 Section 84.34 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.34 - Revocation of certificates of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Revocation of certificates of approval. 84.34 Section 84.34 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

21 CFR 314.160 - Approval of an application or abbreviated application for which approval was previously refused...

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the...

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

PubMed

Deyo, Richard A

2004-01-01

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

The "art" of medicine and the "smokescreen" of the randomized trial off-label use of vascular devices.

PubMed

Ansel, Gary M; Jaff, Michael R

2008-12-01

Once a device is approved for sale in the United States by the Food and Drug Administration (FDA), it can legally be used by doctors to treat any condition a physician determines is medically appropriate. Based on postmarket published data and physician procedural experience, this may even become the standard of care when an alternative device either does not exist or is inferior in performance, even before FDA approval. This right of physicians to practice medicine without FDA approval is Federal law. The off-label use of medical devices for the treatment of peripheral vascular disease has recently become the latest target by groups with interests that have little to do with patient care. This interference has begun to negatively impact the latitude necessary for physicians to best treat their patients. Copyright 2008 Wiley-Liss, Inc.

76 FR 59769 - Clarification on the Division 1.1 Fireworks Approvals Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... test laboratory if the firework device is manufactured in accordance with APA Standard 87-1 (IBR, see... certify that the firework device conforms to the APA Standard 87-1 and that the descriptions and technical... issuing the EX approval. While APA Standard 87-1 references two instances where Division 1.1 fireworks may...

30 CFR 70.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the inner surface of the cyclone on the approved sampling device to assure that it is free of scoring; (4... leaks, and; (5) Examination of the clamping and positioning of the cyclone body, vortex finder and...

9 CFR 381.138 - Unauthorized use or disposition of approved labeling or devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Unauthorized use or disposition of approved labeling or devices. 381.138 Section 381.138 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION...

30 CFR 70.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... clean and in proper working condition by a person certified in accordance with § 70.202 (Certified... components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the...) Examination of the external tubing on the approved sampling device to assure that it is clean and free of...

30 CFR 70.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... clean and in proper working condition by a person certified in accordance with § 70.202 (Certified... components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the...) Examination of the external tubing on the approved sampling device to assure that it is clean and free of...

30 CFR 70.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... clean and in proper working condition by a person certified in accordance with § 70.202 (Certified... components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the...) Examination of the external tubing on the approved sampling device to assure that it is clean and free of...

[Ethic review on clinical experiments of medical devices in medical institutions].

PubMed

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

Current advances in research and clinical applications of PLGA-based nanotechnology

PubMed Central

Lü, Jian-Ming; Wang, Xinwen; Marin-Muller, Christian; Wang, Hao; Lin, Peter H; Yao, Qizhi; Chen, Changyi

2009-01-01

Co-polymer poly(lactic-co-glycolic acid) (PLGA) nanotechnology has been developed for many years and has been approved by the US FDA for the use of drug delivery, diagnostics and other applications of clinical and basic science research, including cardiovascular disease, cancer, vaccine and tissue engineering. This article presents the more recent successes of applying PLGA-based nanotechnologies and tools in these medicine-related applications. It focuses on the possible mechanisms, diagnosis and treatment effects of PLGA preparations and devices. This updated information will benefit to both new and established research scientists and clinical physicians who are interested in the development and application of PLGA nanotechnology as new therapeutic and diagnostic strategies for many diseases. PMID:19435455

Impact of Alternative Medical Device Approval Processes on Costs and Health

PubMed Central

George, Benjamin P.; Venkataraman, Vinayak; Dorsey, E. Ray

2014-01-01

Background Medical devices are often introduced prior to randomized‐trial evidence of efficacy and this slows completion of trials. Alternative regulatory approaches include restricting device use outside of trials prior to trial evidence of efficacy (like the drug approval process) or restricting out‐of‐trial use but permitting coverage within trials such as Medicare's Coverage with Study Participation (CSP). Methods We compared the financial impact to manufacturers and insurers of three regulatory alternatives: (1) limited regulation (current approach), (2) CSP, and (3) restrictive regulation (like the current drug approval process). Using data for patent foramen ovale closure devices, we modeled key parameters including recruitment time, probability of device efficacy, market adoption, and device cost/price to calculate profits to manufacturers, costs to insurers, and overall societal impact on health. Results For manufacturers, profits were greatest under CSP—driven by faster market adoption of effective devices—followed by restrictive regulation. Societal health benefit in total quality‐adjusted life years was greatest under CSP. Insurers’ expenditures for ineffective devices were greatest with limited regulation. Findings were robust over a reasonable range of probabilities of trial success. Conclusions Regulation restricting out‐of‐trial device use and extending limited insurance coverage to clinical trial participants may balance manufacturer and societal interests. PMID:25185975

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.

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

46 CFR 160.076-17 - Approval of design or material changes.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Approval of design or material changes. 160.076-17 Section 160.076-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Inflatable Recreational Personal Flotation Devices § 160.076-17 Approval of...

46 CFR 160.076-17 - Approval of design or material changes.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Approval of design or material changes. 160.076-17 Section 160.076-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Inflatable Recreational Personal Flotation Devices § 160.076-17 Approval of...

46 CFR 160.076-17 - Approval of design or material changes.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Approval of design or material changes. 160.076-17 Section 160.076-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Inflatable Recreational Personal Flotation Devices § 160.076-17 Approval of...

46 CFR 160.076-17 - Approval of design or material changes.

Code of Federal Regulations, 2010 CFR

2010-10-01

... approval before changing PFD production methods. (b) Determinations of equivalence of design, construction... 46 Shipping 6 2010-10-01 2010-10-01 false Approval of design or material changes. 160.076-17... Flotation Devices § 160.076-17 Approval of design or material changes. (a) The manufacturer must submit any...

46 CFR 160.042-5 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... approval. (a) Life raft skids are not subject to formal approval by the Commandant, but for each merchant vessel on which Type A life rafts are to be installed, plans showing the construction and arrangement of the life raft stowage and launching device on the vessel are required to be submitted for approval to...

Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

PubMed

Asano, K; Tanaka, A; Sato, T; Uyama, Y

2013-08-01

Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

Novel Osteoinductive Photo-cross-linkable Chitosan-lactide-fibrinogen Hydrogels Enhance Bone Regeneration in Critical Size Segmental Bone Defects

DTIC Science & Technology

2014-08-01

an absorbable collagen sponge (ACS) is the FDA-approved device for clinical applications including lumbar spine fusion, open tibial fractures, and...fibrinogen on the morphological change of the CL hydrogels was observed. The hydrogel samples were incubated into PBS (pH 7.4) at 37°C for 1 day and... morphology was observed qualitatively using a Zeiss Axiovert 200 microscope (Carl Zeiss Microimaging, Thornwood, NY). Photomicrographs of cells

Investigating Non-Invasive Hemodynamic Monitoring Devices Using Severe Dengue as a Surrogate for Trauma-Induced Shock

DTIC Science & Technology

2014-12-01

dengue hemorrhagic fever. In future work we will continue to evaluate the use of pulse wave forms to predict shock and will assess other...Index Three laboratory Phase I clinical trials have been completed to support a 510(k) application for FDA approval of the first prototype Pulse ... Oximeter with the CRI algorithm and capability for real-time continuous collection of photoplethymographic (PPG) analog signals. An FDA-cleared

Automatic Control and Data Acquisition System for Combustion Laboratory Applications.

DTIC Science & Technology

1982-10-01

O VPI Access~.ion FCr- 1473 2 UNCLASSIFIED Approved for public release; distribution unlimited JAutomatic Control and Data Acquisition System for...unit. The CPU/ROK board includes a 16 bit microprocessor chip which decodes and executes all in- structions, and controls all data transfers. The 12K...in the limited memory space of 32K of the HP-85 33 ACQDTA’ 1) Controls DevicesCRAIN ,2) Acquires Photodiods Output$ 3) Stores Data o Disc 1

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

PubMed

Smith, Colleen

2015-01-01

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

Overview of FDA approval paths optical surgical navigation

NASA Astrophysics Data System (ADS)

Jacobs, Paula M.

2017-02-01

The development of drugs and devices to guide surgical resection of tumors in the United States requires the approval of the US Food and Drug Administration. Because these combine a drug and a device, the regulatory pathways can be confusing, particularly to academics or small companies. This paper discusses some of the issues and provides some guidance in this area.

49 CFR 175.9 - Special aircraft operations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... similar devices carried during a parachute operation. (3) Smoke grenades, flares, and pyrotechnic devices... installation accommodating the smoke grenades, flares, or pyrotechnic devices on the aircraft must be approved...

Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment

PubMed Central

Petersen, Amy J.; Karliner, Leah S.; Tice, Jeffrey A.

2007-01-01

Introduction The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny. Objective To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices? Conclusions Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes. PMID:18095046

77 FR 4219 - FAA-Approved Portable Oxygen Concentrators; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

...-1343; Amdt. No. 121-358] FAA-Approved Portable Oxygen Concentrators; Technical Amendment AGENCY... amending regulations relating to operating rules for FAA approved portable oxygen concentrators (POC... Certain Portable Oxygen Concentrator Devices Onboard Aircraft'' (70 FR 40156). SFAR 106 permits passengers...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests... means approved by the Secretary, and tests for methane shall be made with a methane detector approved by...

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

PubMed

Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

2018-02-23

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

Modelling Public Security Operations: Analysis of the Effect of Key Social, Cognitive, and Informational Factors with Security System Relationship Configurations for Goal Achievement

DTIC Science & Technology

2012-12-01

of MARSEC 2 13 Causing a fire or explosion, conducting blasting or setting off fireworks , including setting a flare or other signalling device...or explosion, conducting blasting or setting off fireworks , including setting a flare or other signalling device without port approval X X X X X X...explosion, conducting blasting or setting off fireworks , including setting a flare or other signalling device without port approval X X X X X X X Non

Regulatory aspects of noninvasive glucose measurements.

PubMed

Gutman, Steve; Bernhardt, Patricia; Pinkos, Arleen; Moxey-Mims, Marva; Knott, Thomas; Cooper, Jean

2002-01-01

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 6 2013-10-01 2013-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 6 2014-10-01 2014-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 6 2012-10-01 2012-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 6 2011-10-01 2011-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.

PubMed

Brooks, Steven S

2017-06-01

Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients. Copyright © 2017. Published by Elsevier Inc.

42 CFR 84.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... state and supplied to the wearer in gaseous form. (g) dBA means sound pressure levels in decibels, as... RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General Provisions § 84.2 Definitions. As..., as evidence of such approval. (c) Approved means conforming to the minimum requirements of this part...

Committee approves bill to boost NIH funding.

PubMed

2015-08-01

A U.S. House of Representatives committee approved the 21st Century Cures Act. If passed by Congress, the bill would boost funding for the NIH and FDA and introduce new strategies for accelerating the approval of drugs and devices. ©2015 American Association for Cancer Research.

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.

Silkworm silk-based materials and devices generated using bio-nanotechnology.

PubMed

Huang, Wenwen; Ling, Shengjie; Li, Chunmei; Omenetto, Fiorenzo G; Kaplan, David L

2018-06-25

Silks are natural fibrous protein polymers that are spun by silkworms and spiders. Among silk variants, there has been increasing interest devoted to the silkworm silk of B. mori, due to its availability in large quantities along with its unique material properties. Silk fibroin can be extracted from the cocoons of the B. mori silkworm and combined synergistically with other biomaterials to form biopolymer composites. With the development of recombinant DNA technology, silks can also be rationally designed and synthesized via genetic control. Silk proteins can be processed in aqueous environments into various material formats including films, sponges, electrospun mats and hydrogels. The versatility and sustainability of silk-based materials provides an impressive toolbox for tailoring materials to meet specific applications via eco-friendly approaches. Historically, silkworm silk has been used by the textile industry for thousands of years due to its excellent physical properties, such as lightweight, high mechanical strength, flexibility, and luster. Recently, due to these properties, along with its biocompatibility, biodegradability and non-immunogenicity, silkworm silk has become a candidate for biomedical utility. Further, the FDA has approved silk medical devices for sutures and as a support structure during reconstructive surgery. With increasing needs for implantable and degradable devices, silkworm silk has attracted interest for electronics, photonics for implantable yet degradable medical devices, along with a broader range of utility in different device applications. This Tutorial review summarizes and highlights recent advances in the use of silk-based materials in bio-nanotechnology, with a focus on the fabrication and functionalization methods for in vitro and in vivo applications in the field of tissue engineering, degradable devices and controlled release systems.

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

PubMed Central

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval. PMID:29422861

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

PubMed

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval.

21 CFR 314.105 - Approval of an application and an abbreviated application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

21 CFR 314.105 - Approval of an application and an abbreviated application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

21 CFR 314.105 - Approval of an application and an abbreviated application.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

21 CFR 314.105 - Approval of an application and an abbreviated application.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

21 CFR 314.105 - Approval of an application and an abbreviated application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA...) FDA will approve an application and issue the applicant an approval letter on the basis of draft... labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed...

Cerebral oximetry in cardiac and major vascular surgery.

PubMed

Fischer, G W; Silvay, G

2010-01-01

We describe the development and current applications of cerebral oximetry (based on near-infrared reflectance spectroscopy) that can be used during cardiac and major vascular surgery to determined brain tissue oxygen saturation. There are presently three cerebral oximetry devices with FDA approval in the United States to measure and monitor cerebral tissue oxygen saturation. 1. INVOS (Somanetics Corporation, Troy, MI - recently COVIDIEN, Boulder, CO); FORE-SIGHT (CAS Medical Systems, Inc. Branford, CT); EQUANOX (Nonin Medical Inc.Minnesota, MN). All devices are portable, non-invasive and easy to use in operating room and intensive care unit. The data provided in these communication may provided information for improvement of perioperative neuromonitoring techniques, and may be crucial in the design of future clinical trials.

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

21 CFR 886.4270 - Intraocular gas.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4270 Intraocular gas. (a) Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure... required. As of May 28, 1976, an approval under section 515 of the act is required before this device may...

49 CFR 451.15 - Application for individual approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

49 CFR 451.15 - Application for individual approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

49 CFR 451.15 - Application for individual approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

49 CFR 451.15 - Application for individual approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

49 CFR 451.15 - Application for individual approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.15 Application for individual approval. (a) For approval of new containers... the container. ...

An emerging network storage management standard: Media error monitoring and reporting information (MEMRI) - to determine optical tape data integrity

NASA Technical Reports Server (NTRS)

Podio, Fernando; Vollrath, William; Williams, Joel; Kobler, Ben; Crouse, Don

1998-01-01

Sophisticated network storage management applications are rapidly evolving to satisfy a market demand for highly reliable data storage systems with large data storage capacities and performance requirements. To preserve a high degree of data integrity, these applications must rely on intelligent data storage devices that can provide reliable indicators of data degradation. Error correction activity generally occurs within storage devices without notification to the host. Early indicators of degradation and media error monitoring 333 and reporting (MEMR) techniques implemented in data storage devices allow network storage management applications to notify system administrators of these events and to take appropriate corrective actions before catastrophic errors occur. Although MEMR techniques have been implemented in data storage devices for many years, until 1996 no MEMR standards existed. In 1996 the American National Standards Institute (ANSI) approved the only known (world-wide) industry standard specifying MEMR techniques to verify stored data on optical disks. This industry standard was developed under the auspices of the Association for Information and Image Management (AIIM). A recently formed AIIM Optical Tape Subcommittee initiated the development of another data integrity standard specifying a set of media error monitoring tools and media error monitoring information (MEMRI) to verify stored data on optical tape media. This paper discusses the need for intelligent storage devices that can provide data integrity metadata, the content of the existing data integrity standard for optical disks, and the content of the MEMRI standard being developed by the AIIM Optical Tape Subcommittee.

How much do physician-entrepreneurs contribute to new medical devices?

PubMed

Smith, Sheryl Winston; Sfekas, Andrew

2013-05-01

As recent public and private initiatives have sought to increase the transparency of physician-industry financial relationships (including calls for restricting collaboration), it is important to understand the extent of physicians' contributions to new medical devices. We quantify the contribution of information from physician-founded startup companies to 170 premarket approval (PMA) applications filed by 4 large incumbent medical device manufacturers over the period 1978-2007. We ask: Are incumbents more likely to incorporate information from physician-founded firms than nonphysician-founded firms? We matched the text in 4 incumbent medical device firms' PMAs (Medtronic, Johnson & Johnson, Boston Scientific, and Guidant) to the text in patent applications of 118 startup companies that received investment from these incumbents between 1978 and 2007. We use a text-matching algorithm to quantify the information contribution from physician and nonphysician-founded startups to incumbent firms' PMAs. We analyze correlates of backward citations and degree of overlap between incumbents' PMAs and startups' patents using negative binomial and tobit regressions. On average, physician-founded companies account for 11% of the information in PMAs, compared with 4% from nonphysician-founded companies. Regression results show that incumbents are significantly more likely to cite physician-founded companies' patents and to incorporate them into new devices. Physicians are an important source of medical device innovation. The results suggest that restrictions on financial relationships between providers and industry, while potentially improving patients' trust, may result in reduced medical innovation if physicians found fewer startups or if incumbent firms reduce investments in physician-founded startups.

Characterization and outcomes of reinterventions in Food and Drug Administration-approved versus trial endovascular aneurysm repair devices.

PubMed

Fairman, Alexander S; Wang, Grace J; Jackson, Benjamin M; Foley, Paul J; Damrauer, Scott M; Kalapatapu, Venkat; Golden, Michael A; Fairman, Ronald M

2018-04-01

Published rates of reintervention after endovascular aneurysm repair (EVAR) range from 10% to 30%. We evaluated a single university center's experience with reinterventions in the context of Food and Drug Administration (FDA)-approved and trial devices. Retrospective data collection was performed for patients who underwent infrarenal EVAR and required reintervention from 2000 to 2016. Trial devices included those used in FDA feasibility and pivotal trials. Time-to-event analysis was performed using Cox regression. Predictors of mortality and explantation were evaluated using logistic regression; survival analysis was performed using Kaplan-Meier methods. From 2000 to 2016, there were 1835 EVARs performed, and 137 patients (116 men; mean age, 72.2 ± 10.0 years) underwent reintervention with a mean aneurysm size of 5.9 ± 1.2 cm. The median follow-up was 5 years with an overall survival of 70.1%. The overall reintervention rate was 7.5%. FDA-approved devices had a reintervention rate of 6.4%, whereas trial devices had a rate of 14.4% (P < .001). For all devices, the most common cause of reintervention was type II endoleak (52.5%), followed by type I endoleak (18.2%), type III endoleak (9.5%), limb kink (7.3%), iliac occlusive disease (5.8%), endotension (1.5%), and other. The overall mean time to first reintervention was 2.3 ± 2.5 years, and univariate Cox regression identified male gender (hazard ratio, 1.91; 95% confidence interval [CI], 1.17-3.10; P = .010) and age at the time of EVAR (hazard ratio, 1.03; 95% CI, 1.01-1.05; P = .006) as risk factors for time to first reintervention. Among patients requiring reintervention, the mean number of reinterventions for trial devices was significantly greater than that for FDA-approved devices (2.18 vs 1.65; P = .01). Trial devices requiring reintervention had a nearly threefold higher odds for the need for more than two reinterventions (odds ratio, 2.88; 95% CI, 1.12-7.37; P = .034). Trial device, cause of reintervention, and type of reintervention were not predictive of the need for explantation or mortality, but the number of reinterventions was significantly associated with the need for explantation (odds ratio, 1.86; 95% CI, 1.17-2.96; P = .012). EVAR device and the need for explantation did not have an impact on mortality. Despite the rigorous nature of patient enrollment in clinical trials and the development of newer iterations of investigational devices, patients undergoing EVAR with trial devices are more likely to undergo a greater number of reinterventions than with FDA-approved devices. Although mortality and the need for explantation were not significantly associated with trial devices, the finding of a greater number of reinterventions highlights the need to properly inform patients willing to partake in investigational device trials. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

45 CFR 12a.10 - Action on approved applications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... REAL PROPERTY TO ASSIST THE HOMELESS § 12a.10 Action on approved applications. (a) Unutilized and underutilized properties. (1) When HHS approves an application, it will so notify the applicant and forward a... 45 Public Welfare 1 2011-10-01 2011-10-01 false Action on approved applications. 12a.10 Section...

45 CFR 12a.10 - Action on approved applications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... REAL PROPERTY TO ASSIST THE HOMELESS § 12a.10 Action on approved applications. (a) Unutilized and underutilized properties. (1) When HHS approves an application, it will so notify the applicant and forward a... 45 Public Welfare 1 2010-10-01 2010-10-01 false Action on approved applications. 12a.10 Section...

30 CFR 18.93 - Application for field approval; filing procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Application for field approval; filing... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.93 Application for field approval; filing...

30 CFR 18.93 - Application for field approval; filing procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Application for field approval; filing... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.93 Application for field approval; filing...

14 CFR 91.1087 - Approval of aircraft simulators and other training devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Approval of aircraft simulators and other... OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES Fractional Ownership Operations Program Management § 91.1087 Approval of aircraft simulators and...

14 CFR 91.1087 - Approval of aircraft simulators and other training devices.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Approval of aircraft simulators and other... OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES Fractional Ownership Operations Program Management § 91.1087 Approval of aircraft simulators and...

14 CFR 91.1087 - Approval of aircraft simulators and other training devices.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Approval of aircraft simulators and other... OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES Fractional Ownership Operations Program Management § 91.1087 Approval of aircraft simulators and...

14 CFR 91.1087 - Approval of aircraft simulators and other training devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Approval of aircraft simulators and other... OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES Fractional Ownership Operations Program Management § 91.1087 Approval of aircraft simulators and...

14 CFR 135.335 - Approval of aircraft simulators and other training devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... OPERATIONS OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD... following requirements: (1) It must be specifically approved for— (i) The certificate holder; and (ii) The..., functional, and other character- istics that are required for approval. (3) Additionally, for aircraft...

14 CFR 91.1087 - Approval of aircraft simulators and other training devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... subpart must meet the following requirements: (1) It must be specifically approved for— (i) The program... maintain the performance, functional, and other characteristics that are required for approval. (3... conform with any modification to the aircraft being simulated that changes the performance, functional, or...

42 CFR 84.36 - Delivery of changed or modified approved respirator.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Delivery of changed or modified approved respirator. 84.36 Section 84.36 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.36 - Delivery of changed or modified approved respirator.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Delivery of changed or modified approved respirator. 84.36 Section 84.36 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.36 - Delivery of changed or modified approved respirator.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Delivery of changed or modified approved respirator. 84.36 Section 84.36 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.36 - Delivery of changed or modified approved respirator.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Delivery of changed or modified approved respirator. 84.36 Section 84.36 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

42 CFR 84.36 - Delivery of changed or modified approved respirator.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Delivery of changed or modified approved respirator. 84.36 Section 84.36 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES...

The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.

PubMed

Adamovich, Ashley; Park, Susie; Siskin, Gary P; Englander, Meridith J; Mandato, Kenneth D; Herr, Allen; Keating, Lawrence J

2015-09-01

The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty. Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.

Qualification and Approval of Personal Computer-Based Aviation Training Devices

DOT National Transportation Integrated Search

1997-05-12

This Advisory Circular (AC) provides information and guidance to potential training device manufacturers and aviation training consumers concerning a means, acceptable to the Administrator, by which personal computer-based aviation training devices (...

Review of emerging surgical robotic technology.

PubMed

Peters, Brian S; Armijo, Priscila R; Krause, Crystal; Choudhury, Songita A; Oleynikov, Dmitry

2018-04-01

The use of laparoscopic and robotic procedures has increased in general surgery. Minimally invasive robotic surgery has made tremendous progress in a relatively short period of time, realizing improvements for both the patient and surgeon. This has led to an increase in the use and development of robotic devices and platforms for general surgery. The purpose of this review is to explore current and emerging surgical robotic technologies in a growing and dynamic environment of research and development. This review explores medical and surgical robotic endoscopic surgery and peripheral technologies currently available or in development. The devices discussed here are specific to general surgery, including laparoscopy, colonoscopy, esophagogastroduodenoscopy, and thoracoscopy. Benefits and limitations of each technology were identified and applicable future directions were described. A number of FDA-approved devices and platforms for robotic surgery were reviewed, including the da Vinci Surgical System, Sensei X Robotic Catheter System, FreeHand 1.2, invendoscopy E200 system, Flex® Robotic System, Senhance, ARES, the Single-Port Instrument Delivery Extended Research (SPIDER), and the NeoGuide Colonoscope. Additionally, platforms were reviewed which have not yet obtained FDA approval including MiroSurge, ViaCath System, SPORT™ Surgical System, SurgiBot, Versius Robotic System, Master and Slave Transluminal Endoscopic Robot, Verb Surgical, Miniature In Vivo Robot, and the Einstein Surgical Robot. The use and demand for robotic medical and surgical platforms is increasing and new technologies are continually being developed. New technologies are increasingly implemented to improve on the capabilities of previously established systems. Future studies are needed to further evaluate the strengths and weaknesses of each robotic surgical device and platform in the operating suite.

6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Procedures for certification of approved products for Homeland Security. (a) Application Procedure. An applicant seeking a Certification of anti-terrorism Technology as an Approved Product for Homeland Security... application for renewal must be made using the “Application for Certification of an Approved Product for...

77 FR 28460 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

...-2010-0159] RIN 2125-AF43 National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Revision AGENCY: Federal Highway Administration (FHWA..., approved by the FHWA, and recognized as the national standard for traffic control devices used on all...

Performance of a new hand-held device for exhaled nitric oxide measurement in adults and children.

PubMed

Alving, K; Janson, C; Nordvall, L

2006-04-20

Exhaled nitric oxide (NO) measurement has been shown to be a valuable tool in the management of patients with asthma. Up to now, most measurements have been done with stationary, chemiluminescence-based NO analysers, which are not suitable for the primary health care setting. A hand-held NO analyser which simplifies the measurement would be of value both in specialized and primary health care. In this study, the performance of a new electrochemical hand-held device for exhaled NO measurements (NIOX MINO) was compared with a standard stationary chemiluminescence unit (NIOX). A total of 71 subjects (6-60 years; 36 males), both healthy controls and atopic patients with and without asthma were included. The mean of three approved exhalations (50 ml/s) in each device, and the first approved measurement in the hand-held device, were compared with regard to NO readings (Bland-Altman plots), measurement feasibility (success rate with 6 attempts) and repeatability (intrasubject SD). Success rate was high (> or = 84%) in both devices for both adults and children. The subjects represented a FENO range of 8-147 parts per billion (ppb). When comparing the mean of three measurements (n = 61), the median of the intrasubject difference in exhaled NO for the two devices was -1.2 ppb; thus generally the hand-held device gave slightly higher readings. The Bland-Altman plot shows that the 95% limits of agreement were -9.8 and 8.0 ppb. The intrasubject median difference between the NIOX and the first approved measurement in the NIOX MINO was -2.0 ppb, and limits of agreement were -13.2 and 10.2 ppb. The median repeatability for NIOX and NIOX MINO were 1.1 and 1.2 ppb, respectively. The hand-held device (NIOX MINO) and the stationary system (NIOX) are in clinically acceptable agreement both when the mean of three measurements and the first approved measurement (NIOX MINO) is used. The hand-held device shows good repeatability, and it can be used successfully on adults and most children. The new hand-held device will enable the introduction of exhaled NO measurements into the primary health care.

Regulatory Challenges for Cartilage Repair Technologies.

PubMed

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Regulatory Challenges for Cartilage Repair Technologies

PubMed Central

Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)–approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product’s attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible. PMID:26069647

Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection.

PubMed

Beck, Adam W; Lombardi, Joseph V; Abel, Dorothy B; Morales, J Pablo; Marinac-Dabic, Danica; Wang, Grace; Azizzadeh, Ali; Kern, John; Fillinger, Mark; White, Rodney; Cronenwett, Jack L; Cambria, Richard P

2017-05-01

United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals. In recent years, The FDA Center for Devices and Radiological Health has been promoting the development and use of patient registries to advance infrastructure and methodologies for medical device investigation. The FDA 2012 document, "Strengthening the National System for Medical Device Post-market Surveillance," highlighted registries as a core foundational infrastructure when linked to other complementary data sources, including embedded unique device identification. The Vascular Quality Initiative (VQI) thoracic endovascular aortic repair for type B aortic dissection project is an innovative method of using quality improvement registries to meet the needs of device evaluation after market approval. Here we report the organization and background of this project and highlight the innovation facilitated by collaboration of physicians, the FDA, and device manufacturers. This effort used an existing national network of VQI participants to capture patients undergoing thoracic endovascular aortic repair for acute type B aortic dissection within a registry that aligns with standard practice and existing quality efforts. The VQI captures detailed patient, device, and procedural data for consecutive eligible cases under the auspices of a Patient Safety Organization (PSO). Patients were divided into a 5-year follow-up group (200 acute; 200 chronic dissections) and a 1-year follow-up group (100 acute; 100 chronic). The 5-year cohort required additional imaging details, and the 1-year group required standard VQI registry data entry. The sample size of patients in each of the 5-year acute and chronic dissection arms was achieved ≤24 months of project initiation, and data capture for the 1-year follow-up group is also nearly complete. Data completeness and follow-up has been excellent, and the two FDA-approved devices for dissection are equally represented. Although the completeness of long-term follow-up is yet to be determined, the rapidity of data collection supports the use of this construct for device assessment after market approval. The alignment of this effort with routine clinical practice and ongoing quality improvement initiatives is critical and has required minimal additional effort by practitioners, thus facilitating patient inclusion. Importantly, the success and development of this unique project has helped inform FDA strategy for future device evaluation after market approval. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

7 CFR 58.227 - Sampling device.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Sampling device. 58.227 Section 58.227 Agriculture....227 Sampling device. If automatic sampling devices are used, they shall be constructed in such a.... The type of sampler and the sampling procedure shall be as approved by the Administrator. ...

7 CFR 58.227 - Sampling device.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Sampling device. 58.227 Section 58.227 Agriculture....227 Sampling device. If automatic sampling devices are used, they shall be constructed in such a.... The type of sampler and the sampling procedure shall be as approved by the Administrator. ...

Innovation under Regulatory Uncertainty: Evidence from Medical Technology

PubMed Central

Stern, Ariel Dora

2016-01-01

This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34 percent (7.2 months) longer than follow-on entrants in regulatory approval. Back-of-the- envelope calculations suggest that the cost of a delay of this length is upwards of 7 percent of the total cost of bringing a new high-risk device to market. Considering potential explanations, I find that approval times are largely unrelated to technological novelty, but are meaningfully reduced by the publication of objective regulatory guidelines. Finally, I consider how the regulatory process affects small firms’ market entry patterns and find that small firms are less likely to be pioneers in new device markets, a fact consistent with relatively higher costs of doing so for more financially constrained firms. PMID:28652646

78 FR 31885 - Patent Term Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

... patents for drug products, medical devices, food additives, or color additives are potentially eligible... using the approved product, or a method of manufacturing the approved product. 35 U.S.C. 156(d) also...

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

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

Connor, Michael J.; University of California Irvine School of Medicine, Irvine, California; Tringale, Kathryn

Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Resultsmore » for RODs were compared with those for other devices by Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.« less

77 FR 429 - Clarification and Further Guidance on the Fireworks Approvals Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-05

...) and the American Pyrotechnic Association (APA) Standard 87-1. PHMSA understands that it is a common... approval is requested conforms to the APA Standard 87-1, and the descriptions and technical information... manufacturer must sign and certify that the device for which the approval is requested conforms to the APA...

46 CFR 160.077-7 - Procedure for approval of design or material revision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... being used in any production of PFDs. (b) Determinations of equivalence of design, construction, and... 46 Shipping 6 2010-10-01 2010-10-01 false Procedure for approval of design or material revision... Personal Flotation Devices § 160.077-7 Procedure for approval of design or material revision. (a) Each...

49 CFR 451.11 - Application for approval-general.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

49 CFR 451.11 - Application for approval-general.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

49 CFR 451.11 - Application for approval-general.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

49 CFR 451.11 - Application for approval-general.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

49 CFR 451.11 - Application for approval-general.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.11 Application for approval-general. (a) An owner of a new container, or a...

21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... application for a drug product becomes effective on the date FDA issues an approval letter under § 314.105 for... on the date FDA issues an approval letter under § 314.105 if the applicant certifies under § 314.50(i...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General Provisions § 84.2 Definitions. As...) Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres. (j) Respirators for escape only means respiratory devices...

42 CFR 84.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General Provisions § 84.2 Definitions. As...) Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres. (j) Respirators for escape only means respiratory devices...

42 CFR 84.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General Provisions § 84.2 Definitions. As...) Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres. (j) Respirators for escape only means respiratory devices...

Drugs and Medical Devices: Adverse Events and the Impact on Women’s Health

PubMed Central

Carey, Jennifer L.; Nader, Nathalie; Chai, Peter R.; Carreiro, Stephanie; Griswold, Matthew K.; Boyle, Katherine L.

2018-01-01

A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. PMID:28069260

49 CFR 173.340 - Tear gas devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Tear gas devices. 173.340 Section 173.340... SHIPMENTS AND PACKAGINGS Gases; Preparation and Packaging § 173.340 Tear gas devices. (a) Packagings for tear gas devices must be approved prior to initial transportation by the Associate Administrator. (b...

21 CFR 812.66 - Significant risk device determinations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Significant risk device determinations. 812.66... risk device determinations. If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii), involves a significant risk device, it shall so notify the investigator and, where...

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...

A History of the Sonocare CST-100: The First FDA-approved HIFU Device

NASA Astrophysics Data System (ADS)

Muratore, Robert

2006-05-01

The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

Preliminary Evaluation Of Commercial Supercapacitors For Space Applications

NASA Astrophysics Data System (ADS)

Gineste, Valery; Loup, Didier; Mattesco, Patrick; Neugnot, Nicolas

2011-10-01

Supercapacitors are identified since years as a new technology enabling energy storage together with high power delivery capability to the system. A recent ESA study [1] led by Astrium has demonstrated the interest of these devices for space application, providing that reliability and end of life performances are demonstrated. A realistic commercial on the shelf (COTS) approach (or with limited design modification approved by potential suppliers) has been favoured (as for batteries). This paper presents preliminary test results done by Astrium on COTS supercapacitors: accelerated life tests, calendar life tests, technology analyses. Based on these results, assessment and lessons learnt are drawn in view of future exhaustive supercapacitor validation and future qualification.

Considerations for an institution for evaluation of diabetes technology devices to improve their quality in the European Union.

PubMed

Heinemann, Lutz; Freckmann, Guido; Koschinsky, Theodor

2013-03-01

All medical devices used for self-monitoring of blood glucose (BG), insulin injection, continuous subcutaneous insulin infusion, and continuous glucose monitoring in the European Union (EU) must have a Communauté Européenne (CE) mark. However, the approval process for obtaining this mark is different from that used by the European Medicines Agency in the EU for drugs or by the Food and Drug Administration in the United States for such medical and in vitro diagnostic devices. The notified bodies involved in the CE mark process perform this evaluation in cooperation with the manufacturers. They have only limited diabetes know-how; they have to handle all kinds of medical devices. There are devices for therapy on the market in the EU (i.e., they have market approval) that do not fulfill quality requirements, as indicated, for example, in the international norm ISO 15197 for BG test systems. Evaluation of the performance of such systems is usually provided by the manufacturers. What is missing in the EU is an independent institution that performs regular and critical evaluation of the quality of devices used for diabetes therapy before and also after their market approval. The work of such an institution would focus on BG test systems (these represent two-thirds of the market of medical devices for diabetes treatment) but would also evaluate the performance of other devices. It has to be clarified what legal framework is required for such an institution and how it can be financed; probably this can be done in a shared manner by the manufacturers of such devices and the health insurance companies. Positive evaluation results should be a prerequisite prior to any reimbursement for such devices. © 2013 Diabetes Technology Society.

9 CFR 317.4 - Labeling approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Devices, except for generically approved labeling authorized for use in § 317.5(b). The management of the... carcass ink brands and meat food product ink and burning brands, which comply with parts 312 and 316 of...

40 CFR Table 8 to Subpart Eeee of... - Continuous Compliance With Emission Limits

Code of Federal Regulations, 2010 CFR

2010-07-01

..., items 1 through 6 a. Reduce total organic HAP (or, upon approval, TOC) emissions from the closed vent... organic HAP (or, upon approval, TOC) in the exhaust of combustion devices i. Performing CMS monitoring and... HAP (or, upon approval, TOC) emissions during the loading of organic liquids from the closed vent...

40 CFR Table 6 to Subpart Eeee of... - Initial Compliance With Emission Limits

Code of Federal Regulations, 2010 CFR

2010-07-01

... approval, TOC) emissions by at least 95 weight-percent, or as an option for nonflare combustion devices to an exhaust concentration of ≤20 ppmv Total organic HAP (or, upon approval, TOC) emissions, based on..., or new affected source Reduce total organic HAP (or, upon approval, TOC) emissions from the loading...

46 CFR 160.077-7 - Procedure for approval of design or material revision.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Procedure for approval of design or material revision. 160.077-7 Section 160.077-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hybrid Inflatable Personal Flotation Devices § 160.077-7 Procedure...

46 CFR 160.077-7 - Procedure for approval of design or material revision.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Procedure for approval of design or material revision. 160.077-7 Section 160.077-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hybrid Inflatable Personal Flotation Devices § 160.077-7 Procedure...

46 CFR 160.077-7 - Procedure for approval of design or material revision.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Procedure for approval of design or material revision. 160.077-7 Section 160.077-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Hybrid Inflatable Personal Flotation Devices § 160.077-7 Procedure...

Quantum 1/f Noise in High Technology Applications Including Ultrasmall Structures and Devices

DTIC Science & Technology

1991-07-15

chaos nature of 1/f noise in infrared detectors . 20. 0ISTRIBUTCN/AVAJLABi3LITY OF ABSTRACT j21. Ai3STR.ACT SECURITY fLASS.FiCATION (ZUN.’CASSIF!ED...of 1/f noise in infrared detectors . Approved .or .UnjtlC relSS* distribution unlimited AIR FrnPc COF SCIEMTIFIC RESEARCR (knSC) NOTICE OF T1SITTAL...in ultrasmall BJT’s was found to agree reasonably with the experiment. Finally, the fractional dimension of band- limited quantum 1/f noise was deter

Development of Advanced Li Rich xLi2MO3 (1-x)LiMO2 Composite Cathode for High Capacity Li Ion Batteries

DTIC Science & Technology

2016-12-22

importance. Among advanced energy storage devices, lithium - ion batteries are remarkable systems due to their high energy density, high power density...and well cycled performance with considerable reliability. Lithium - ion batteries have been playing an important role in various application fields...Li0.24Mn0.55Co0.14Ni0.07]O2 cathode material for lithium ion batteries . Solid State Ionics, 2013. 233: p. 12-19. DISTRIBUTION A. Approved for public release

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

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

Connor, Michael J.; Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California; Marshall, Deborah C.

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact).more » Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer–user training may help mitigate these events.« less

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

PubMed

DiMasi, Joseph A

2013-06-01

Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean approval-phase time during the study period for applications that received a standard review rating from the FDA was substantially shorter for supplements compared to original uses, but the differences for applications that received a priority review rating from the FDA were negligible. Development of and regulatory approval for new uses of already-approved drugs and biologics is an important source of innovation by biopharmaceutical firms. Despite rising development costs, the output of new-use approvals has remained stable in recent years, driven largely by the pursuit of new pediatric indications. FDA approval-phase times have generally declined substantially for all types of applications since the mid-1990s following legislation that provided a new source of income for the agency. However, while the resources needed to review supplemental applications are likely lower in general than for original-use approvals, the approval-phase times for important new uses are no lower than for important original-use applications. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

Early application of an intermittent pneumatic compression device is safe and results in proximal arteriovenous fistula enlargement.

PubMed

Desai, Sanjay; Mitra, Amit; Arkans, Ed; Singh, Tej M

2018-05-01

Delays in arteriovenous fistula maturation can cause care delays and increased costs. Increased distention pressure and intermittent wall shear stress may dilate veins based on prior research. Early use of non-invasive devices may help assist clinical arteriovenous fistula dilation. This was an Institutional Review Board approved study. After arteriovenous fistula creation, a novel, intermittent pneumatic compression device (Fist Assist ® ) was applied 15 cm proximal to arteriovenous fistula enabling 60 mmHg of cyclic compression for 6 h daily for 30 days. Among the patients who completed 1 month follow-up, 30 (n = 30) arteriovenous fistula patients were in the study arm to test vein dilation with Fist Assist. Controls (n = 16) used a sham device. Vein size was measured and recorded at baseline and after 30 days by duplex measurement. Clinical results (percentage increase) were recorded and tested for significance. No patients experienced thrombosis or adverse effects. Patient compliance and satisfaction was high. After 1 month, the mean percentage increase in vein diameter in the Fist Assist treatment group was significantly larger (p = 0.026) than controls in the first 5 mm segment of the fistula after the anastomosis. All fistulas treated with Fist Assist are still functional with no reported thrombosis or extravasations. Early application of an intermittent pneumatic compression device may assist in arteriovenous fistula dilation and are safe. Non-invasive devices like Fist Assist may have clinical utility to help fistulae development and decrease costs as they may eventually assist maturation.

Control of silk microsphere formation using polyethylene glycol (PEG).

PubMed

Wu, Jianbing; Zheng, Zhaozhu; Li, Gang; Kaplan, David L; Wang, Xiaoqin

2016-07-15

A one step, rapid method to prepare silk microspheres was developed, with particle size controlled by the addition of polyethylene glycol (PEG). PEG molecular weight (4.0K-20.0KDa) and concentration (20-50wt%), as well as silk concentration (5-20wt%), were key factors that determined particle sizes varying in a range of 1-100μm. Addition of methanol to the PEG-silk combinations increased the content of crystalline β-sheet in the silk microspheres. To track the distribution and degradation of silk microspheres in vivo, 3-mercaptopropionic acid (MPA)-coated CdTe quantum dots (QDs) were physically entrapped in the silk microspheres. QDs tightly bound to the β-sheet domains of silk via hydrophobic interactions, with over 96% of the loaded QDs remaining in the silk microspheres after exhaustive extraction. The fluorescence of QDs-incorporated silk microspheres less stable in cell culture medium than in phosphate buffer solution (PBS) and water. After subcutaneous injection in mice, microspheres prepared from 20% silk (approx. 30μm diameter particles) still fluoresced at 24h, while those prepared from 8% silk (approx. 4μm diameter particles) and free QDs were not detectable, reflecting the QDs quenching and particle size effect on microsphere clearance in vivo. The larger microspheres were more resistant to cell internalization and degradation. Since PEG is an FDA-approved polymer, and silk is FDA approved for some medical devices, the methods developed in the present study will be useful in a variety of biomedical applications where simple, rapid and scalable preparation of silk microspheres is required. The work is of significance to the biomaterial and controlled release society because it provides a new option for fabricating silk microspheres in one simple step of mixing silk and polyethylene glycol (PEG), with the size and properties of microspheres controllable by PEG molecular weight as well as PEG and silk concentrations. Although fabrication of silk microspheres have been reported previously using spray-drying, liposome-templating, polyvinyl alcohol (PVA) emulsification, etc., applications were hindered due to harsh conditions (temperature, solvents, etc.) and complicated procedures used as well as low yield and less controllable particle size (usually <10μm). Since PEG is an FDA-approved polymer, and silk is FDA approved for some medical devices, the methods developed in the present study will be useful in a variety of biomedical applications where simple, rapid and scalable preparation of silk microspheres is required. Copyright © 2016 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

30 CFR 36.30 - Rerailing device.

Code of Federal Regulations, 2010 CFR

2010-07-01

... MINING PRODUCTS APPROVAL REQUIREMENTS FOR PERMISSIBLE MOBILE DIESEL-POWERED TRANSPORTATION EQUIPMENT Construction and Design Requirements § 36.30 Rerailing device. All mobile diesel-powered transportation... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Rerailing device. 36.30 Section 36.30 Mineral...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

PubMed

Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E

Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. To identify the reasons that FDA marketing approval for new drugs was delayed or denied. A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval. Reasons for delayed FDA approval or nonapproval of NME applications. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals (61 of 80 never approved [76.3%] vs 28 of 71 eventually approved [39.4%]; difference, 36.9% [95% CI, 20.25% to 50.86%]; P < .001). Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable study end points, accounted for significant delays in the approval of new drugs. Understanding the reasons for previous failures is helpful to improve the efficiency of clinical development for new drugs.

24 CFR 581.10 - Action on approved applications.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 3 2011-04-01 2010-04-01 true Action on approved applications. 581... URBAN DEVELOPMENT COMMUNITY FACILITIES USE OF FEDERAL REAL PROPERTY TO ASSIST THE HOMELESS § 581.10 Action on approved applications. (a) Unutilized and underutilized properties. (1) When HHS approves an...

77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

... ADVIA Centaur Anti- January 20, 2012. Diagnostics Inc. HBs2 Assay and Quality Control Material. P100005... Flowonix Medical, Prometra February 7, 2012. Inc. (approved under Programmable Medasys, Inc.). Infusion...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

14 CFR 121.405 - Training program and revision: Initial and final approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... aids, devices, methods, and procedures listed in the certificate holder's curriculum as set forth in § 121.403 that increase the quality and effectiveness of the teaching-learning process. If approval of...

21 CFR 814.80 - General.

Code of Federal Regulations, 2010 CFR

2010-04-01

... APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.80 General. A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions...

42 CFR 84.70 - Self-contained breathing apparatus; description.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self..., including all completely assembled, portable, self-contained devices designed for use as respiratory...

42 CFR 84.70 - Self-contained breathing apparatus; description.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self..., including all completely assembled, portable, self-contained devices designed for use as respiratory...

42 CFR 84.70 - Self-contained breathing apparatus; description.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self..., including all completely assembled, portable, self-contained devices designed for use as respiratory...

49 CFR 107.709 - Processing of an application for approval, including an application for renewal or modification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Processing of an application for approval..., Registrations and Submissions § 107.709 Processing of an application for approval, including an application for... before the disposition of an application. (b) At any time during the processing of an application, the...

Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

PubMed

Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

2017-01-01

A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Integrated Microbatteries for Implantable Medical Devices

NASA Technical Reports Server (NTRS)

Whitacre, Jay; West, William

2008-01-01

Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medical devices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...

21 CFR 314.125 - Refusal to approve an application.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... the application under section 505(d) of the act, if: (1) FDA sends the applicant a complete response... question of whether the application is approvable; and (3) FDA finds that any of the reasons given in...