FDA, CE mark or something else?-Thinking fast and slow.

PubMed

Mishra, Sundeep

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

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.

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

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.

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.

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.

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.

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.

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

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

77 FR 68784 - Standard Test Procedures Approval Process for Respirators To Be Used in Wildland Fire-Fighting...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... regulations allow. Because manufacturers have not yet developed respiratory protection for this occupational...-approved filtering facepiece respirators which are not designed for this use, or no respiratory protection... respiratory protective devices designed for the inhalation hazards of this occupational setting. On July 10...

Innovations in design and technology. The story of hip arthroplasty.

PubMed

Amstutz, H C

2000-09-01

The current study reviews the early history of surgeon-initiated trial and error development in hip joint arthroplasty and the subsequent methodological evolution to proper criteria for hypothesis testing using bioengineers and other research scientists. The interplay and relationships to industry, universities, scientific organizations, and the Food and Drug Administration with respect to device development in hip arthroplasty are reviewed. The ethics of and responsibilities to involved parties are outlined, citing the history of many contemporary developments. Examples are provided from the evolution and introduction of unsuccessful innovations, and the problems inherent in the current methodology of the approval process from the Food and Drug Administration using the 5-10K, Investigative Device Exemption, and the Pre-Market Approval protocols. The pros and cons of randomized trials for devices are outlined with the conclusion that they are not appropriate for device introduction. The proper, rational methodology for introduction of new devices is a phased-in clinical trial process after pertinent bench testing. Finally, the ethical dilemmas created by managed care are addressed. Industry involvements of the surgeon-spokesmen are cited.

Declassifying coverage. New guidance documents issued by the CMS may clarify the great unknown of Medicare coverage determination.

PubMed

Barr, Paul

2005-03-21

Heard of Section 731 of the Medicare Modernization Act? The provision, meant to clear up the generally murky and unwieldy Medicare reimbursement approval process, could quicken the national approval process for medical procedures and devices. The changes will create a more definable approach to OK'ing new technologies. "I like the idea of bringing more science to bear," says Richard Pico, left.

Medical device development.

PubMed

Panescu, Dorin

2009-01-01

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

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.

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.

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.

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.

78 FR 52219 - State of Georgia Relinquishment of Sealed Source and Device Evaluation and Approval Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0196] State of Georgia Relinquishment of Sealed Source and... evaluate and approve sealed source and device (SS&D) applications in the State of Georgia and approved the... regulatory authority for evaluating and approving sealed source and device applications on August 20, 2013...

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.

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.

New technology in electrophysiology: FDA process and perspective.

PubMed

Selzman, Kimberly A; Fellman, Mark; Farb, Andrew; de Del Castillo, Sergio; Zuckerman, Bram

2016-10-01

The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.

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.

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...

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

PubMed

1998-05-18

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

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...

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

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...

Off-label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121

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

Thomadsen, Bruce R.; Thompson, Heaton H. II; Jani, Shirish K.

Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use canmore » be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the approval process, along with manufacturers' responsibilities, labeling, marketing and promotion, and off-label use. This is an educational and descriptive report and does not contain prescriptive recommendations. This report addresses the role of the medical physicist in clinical situations involving off-label use. Case studies in radiation therapy are presented. Any mention of commercial products is for identification only; it does not imply recommendations or endorsements of any of the authors or the AAPM. The full report, containing extensive background on off-label use with several appendices, is available on the AAPM website (http://www.aapm.org/pubs/reports/).« less

The new collaborative path in medical device development: the medical device innovation consortium.

PubMed

Kampfrath, Thomas; Cotten, Steven W

2013-10-01

The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

PubMed

Ashar, B S; Dang, J M; Krause, D; Luke, M C

2011-12-01

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

21 CFR 814.45 - Denial of approval of a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

21 CFR 814.45 - Denial of approval of a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

21 CFR 814.45 - Denial of approval of a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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...

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...

78 FR 19714 - User Fees and Refunds for Premarket Approval Applications and Device Biologics License...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

...] User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications... availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and... for single copies of the guidance document entitled ``User Fees and Refunds for Premarket Approval...

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...

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

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.

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.

Abbreviations for device names: a proposed methodology with specific examples.

PubMed

Alam, Murad; Dover, Jeffrey S; Alam, Murad; Goldman, Mitchel P; Kaminer, Michael S; Orringer, Jeffrey; Waldorf, Heidi; Alam, Murad; Avram, Mathew; Cohen, Joel L; Draelos, Zoe Diana; Dover, Jeffrey S; Hruza, George; Kilmer, Suzanne; Lawrence, Naomi; Lupo, Mary; Metelitsa, Andrei; Nestor, Mark; Ross, E Victor

2013-04-01

Many devices used in dermatology lack generic names. If investigators use commercial device names, they risk the appearance of bias. Alternatively, reliance on ad-hoc names and abbreviations may confuse readers who do not recognize these. To develop a system for assigning abbreviations to denote devices commonly used in dermatology. Secondarily, to use this system to create abbreviations for FDA-approved neurotoxins and prepackaged injectable soft-tissue augmentation materials. The American Society for Dermatologic Surgery convened a Lexicon Task Force in March 2012. One charge of this Task Force was to develop criteria for assigning abbreviations to medical devices. A modified consensus process was used. Abbreviations to denote devices were to be: based on a standardized approach; transparent to the casual reader; markedly brief; and in all cases, different than the commercial names. Three-letter all caps abbreviations, some with subscripts, were assigned to denote each of the approved neurotoxins and fillers. A common system of abbreviations for medical devices in dermatology may avoid the appearance of bias while ensuring effective communication. The proposed system may be expanded to name other devices, and the ensuing abbreviations may be suitable for journal articles, continuing medical education lectures, or other academic or clinical purposes. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, 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.

A drug's life: the pathway to drug approval.

PubMed

Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

2013-10-01

In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

The use of Food and Drug Administration 510(k) notifications in patent litigation.

PubMed

Tolomeo, Deborah E

2004-01-01

The U.S. Food and Drug Administration (FDA) 510(k) approval process provides medical device companies with the ability to market a device after the company establishes that the device to the marketed is "substantially equivalent" to one or more predicate devices. Companies that submit 510(k) notifications should be aware, however, that a 510(k) notification is a public document that may later reappear as evidence in patent litigation. Courts have considered 510(k) notifications to be relevant evidence in determining direct and contributory infringement, patent invalidity, and patent unenforceability due to inequitable conduct before the U.S. Patent and Trademark Office (USPTO). In one case, the court held that a substantial equivalence determination by FDA constituted evidence that can be "construed as an admission of infringement." The court also has relied on a 510(k) notification to support a finding of personal liability for a corporate officer who signed the 510(k) notification to be evidence of willful and deliberate conduct, and have awarded treble damages and reasonable attorney's fees to the prevailing party. The potential for increased risk in patent litigation is important for practitioners in the medical device industry, because more than seventy-five percent of medical devices are approved for marketing through the 510(k) process. This article reviews a number of patent cases in which a court has admitted a 510(k) notification as relevant evidence, and proposes general strategies for avoiding these situations.

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 250.1201 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Resources BUREAU OF OCEAN ENERGY MANAGEMENT, REGULATION, AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR... measurement. The measured volumes are used in the allocation process. Liquid hydrocarbons (free liquids... at which custody transfer takes place (not necessarily a royalty meter). Seal—a device or approved...

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...

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.

"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.

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...

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...

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

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...

46 CFR 164.019-9 - Procedure for acceptance of revisions of design, process, or materials.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Procedure for acceptance of revisions of design, process, or materials. 164.019-9 Section 164.019-9 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Personal Flotation Device Components § 164.019-9 Procedure fo...

46 CFR 164.019-9 - Procedure for acceptance of revisions of design, process, or materials.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Procedure for acceptance of revisions of design, process, or materials. 164.019-9 Section 164.019-9 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Personal Flotation Device Components § 164.019-9 Procedure fo...

46 CFR 164.019-9 - Procedure for acceptance of revisions of design, process, or materials.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Procedure for acceptance of revisions of design, process, or materials. 164.019-9 Section 164.019-9 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Personal Flotation Device Components § 164.019-9 Procedure fo...

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.

77 FR 9865 - Clarification on the Division 1.1 Fireworks Approvals Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-21

... APA Standard 87-1 (IBR, see Sec. 171.7), and the device passes the thermal stability test. Additionally, the applicant must certify that the firework device conforms to the APA Standard 87-1 and that... approval. While APA Standard 87-1 contains two instances where Division 1.1 fireworks may be approved under...

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...

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, 2014 CFR

2014-07-01

...) Methane monitoring devices and portable, battery-powered, self-contained devices used for measuring methane, other gases, and contaminants in mine air shall be approved by MSHA under the applicable... shall not be used to test for methane except as supplementary devices. (2) Flame safety lamps shall not...

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, 2013 CFR

2013-07-01

...) Methane monitoring devices and portable, battery-powered, self-contained devices used for measuring methane, other gases, and contaminants in mine air shall be approved by MSHA under the applicable... shall not be used to test for methane except as supplementary devices. (2) Flame safety lamps shall not...

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, 2012 CFR

2012-07-01

...) Methane monitoring devices and portable, battery-powered, self-contained devices used for measuring methane, other gases, and contaminants in mine air shall be approved by MSHA under the applicable... shall not be used to test for methane except as supplementary devices. (2) Flame safety lamps shall not...

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...

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.

Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice.

PubMed

1998-01-29

The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1997, of the approval of the application.

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.

40 CFR Table 12 to Subpart G of... - Monitoring Requirements for Treatment Processes

Code of Federal Regulations, 2013 CFR

2013-07-01

... Appropriate methods as specified in § 63.143 and as approved by permitting authority. 2. Steam stripper (i... recorder. (ii) Wastewater feed mass flow rate; and Continuously Liquid flow meter installed at stripper... operating temperature Continuously (A) Liquid temperature monitoring device installed at stripper influent...

40 CFR Table 12 to Subpart G of... - Monitoring Requirements for Treatment Processes

Code of Federal Regulations, 2010 CFR

2010-07-01

... Appropriate methods as specified in § 63.143 and as approved by permitting authority. 2. Steam stripper (i... recorder. (ii) Wastewater feed mass flow rate; and Continuously Liquid flow meter installed at stripper... operating temperature Continuously (A) Liquid temperature monitoring device installed at stripper influent...

40 CFR Table 12 to Subpart G of... - Monitoring Requirements for Treatment Processes

Code of Federal Regulations, 2011 CFR

2011-07-01

... Appropriate methods as specified in § 63.143 and as approved by permitting authority. 2. Steam stripper (i... recorder. (ii) Wastewater feed mass flow rate; and Continuously Liquid flow meter installed at stripper... operating temperature Continuously (A) Liquid temperature monitoring device installed at stripper influent...

40 CFR Table 12 to Subpart G of... - Monitoring Requirements for Treatment Processes

Code of Federal Regulations, 2014 CFR

2014-07-01

... Appropriate methods as specified in § 63.143 and as approved by permitting authority. 2. Steam stripper (i... recorder. (ii) Wastewater feed mass flow rate; and Continuously Liquid flow meter installed at stripper... operating temperature Continuously (A) Liquid temperature monitoring device installed at stripper influent...

40 CFR Table 12 to Subpart G of... - Monitoring Requirements for Treatment Processes

Code of Federal Regulations, 2012 CFR

2012-07-01

... Appropriate methods as specified in § 63.143 and as approved by permitting authority. 2. Steam stripper (i... recorder. (ii) Wastewater feed mass flow rate; and Continuously Liquid flow meter installed at stripper... operating temperature Continuously (A) Liquid temperature monitoring device installed at stripper influent...

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.

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

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."

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. ...

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

PubMed Central

2013-01-01

Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. This review provides an introduction to such considerations with the aim of generating more extensive discussion for study design, assay performance, and regulatory approval in the process of translating new proteomic biomarkers from discovery into cancer diagnostics. We first describe the analytical requirements for a robust clinical biomarker assay, including concepts of precision, trueness, specificity and analytical interference, and carryover. We next introduce the clinical considerations of diagnostic accuracy, receiver operating characteristic analysis, positive and negative predictive values, and clinical utility. We finish the review by describing components of the FDA approval process for protein-based biomarkers, including classification of biomarker assays as medical devices, analytical and clinical performance requirements, and the approval process workflow. While we recognize that the road from biomarker discovery, validation, and regulatory approval to the translation into the clinical setting could be long and difficult, the reward for patients, clinicians and scientists could be rather significant. PMID:24088261

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...

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.

76 FR 38370 - Western Pacific Fisheries; Approval of a Marine Conservation Plan for Pacific Insular Areas...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-30

... seine vessels fishing on fish aggregation devices in the PRIA. b. Support tagging studies in the PRIA to... characteristics of federally managed species through bio-sampling. Objective 2. Conduct education and outreach to...-making process by supporting education and outreach activities related to sustainable fisheries...

9 CFR 318.305 - Equipment and procedures for heat processing systems.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ensure a supply of clean, dry air. The recorder timing mechanism shall be accurate. (i) Chart-type... filter systems to ensure a supply of clean, dry air. (ii) Pressure recording device. Each retort shall be... section. (2) Cooling canal water shall be chlorinated or treated with a chemical approved by the...

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

Regulatory issues for computerized electrocardiographic devices.

PubMed

Muni, Neal I; Ho, Charles; Mallis, Elias

2004-01-01

Computerized electrocardiogram (ECG) devices are regulated in the U.S. by the FDA Center for Devices and Radiological Health (CDRH). This article aims to highlight the salient points of the FDA regulatory review process, including the important distinction between a "tool" claim and a "clinical" claim in the intended use of a computerized ECG device. Specifically, a tool claim relates to the ability of the device to accurately measure a certain ECG parameter, such as T-wave alternans (TWA), while a clinical claim imputes a particular health hazard associated with the identified parameter, such as increased risk of ventricular tachyarrhythmia or sudden death. Given that both types of claims are equally important and receive the same regulatory scrutiny, the manufacturer of a new ECG diagnostic device should consider the distinction and regulatory pathways for approval between the two types of claims discussed in this paper.

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...

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.

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

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

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...

[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.

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.

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...

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.

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.

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...

Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

PubMed

2010-11-05

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

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 814.40 - Time frames for reviewing a PMA.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

21 CFR 814.40 - Time frames for reviewing a PMA.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

21 CFR 814.40 - Time frames for reviewing a PMA.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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...

How are drugs approved? Part 1: the evolution of the Food and Drug Administration.

PubMed

Howland, Robert H

2008-01-01

The discovery, development, and marketing of drugs for clinical use is a process that is complex, arduous, expensive, highly regulated, often criticized, and sometimes controversial. In the United States, the Food and Drug Administration (FDA) is the governmental agency responsible for regulating the development and marketing of drugs, medical devices, biologics, foods, cosmetics, radiation-emitting electronic devices, and veterinary products, with the objective of ensuring their safety and efficacy. As part of a broad overview of the drug development process, this article will describe the historical evolution of the FDA. This will provide background for two subsequent articles in this series, which will describe the ethical foundations of clinical research and hethe stages of drug development.

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...

Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

PubMed Central

Morrison, Robert J.; Kashlan, Khaled N.; Flanangan, Colleen L.; Wright, Jeanne K.; Green, Glenn E.; Hollister, Scott J.

2015-01-01

Abstract Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device. PMID:26243449

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.

[Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].

PubMed

Lang, Achim

2014-01-01

Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. Copyright © 2013. Published by Elsevier GmbH.

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...

Integration of new technology into clinical practice after FDA approval.

PubMed

Govil, Ashul; Hao, Steven C

2016-10-01

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

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.

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...

Adopting new technologies in stroke rehabilitation: the influence of the US health care system.

PubMed

Stein, J

2009-06-01

Stroke rehabilitation is entering a new era of technological innovation, including the development of robotic aids for therapy, peripheral electrical stimulation devices, and brain stimulation systems. These technologies have the potential to significantly improve the efficiency and efficacy of stroke rehabilitation. The United States health care system creates both opportunities for new technologies to be created and adopted, as well as important barriers. Inadequate support of clinical trials of the efficacy of new non-invasive devices is a particular concern for practitioners seeking to determine if new devices are clinically useful. Government support of clinical trials of efficacy, coupled with reform of FDA approval processes for novel therapies, is needed to create an evidence-based approach to improving stroke rehabilitation.

Electronic voltage and current transformers testing device.

PubMed

Pan, Feng; Chen, Ruimin; Xiao, Yong; Sun, Weiming

2012-01-01

A method for testing electronic instrument transformers is described, including electronic voltage and current transformers (EVTs, ECTs) with both analog and digital outputs. A testing device prototype is developed. It is based on digital signal processing of the signals that are measured at the secondary outputs of the tested transformer and the reference transformer when the same excitation signal is fed to their primaries. The test that estimates the performance of the prototype has been carried out at the National Centre for High Voltage Measurement and the prototype is approved for testing transformers with precision class up to 0.2 at the industrial frequency (50 Hz or 60 Hz). The device is suitable for on-site testing due to its high accuracy, simple structure and low-cost hardware.

Medical regulation of cognitive enhancement devices: some concerns

PubMed Central

King, Mike; Gavaghan, Colin; McMillan, John

2014-01-01

The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration. PMID:27774173

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.

[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").

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...

Standards for Lithotripter Performance

NASA Astrophysics Data System (ADS)

Schultheiss, Reiner; Doerffel, Michael

2008-09-01

Standards for lithotripsy have been developed by the International Electrotechnical Commission (IEC) and the FDA. In addition to the existing regulations and norms for the manufacturers, special standards were developed to address a treatment method developed in the early 1980's using extracorporeal shock waves. Initially, the FDA regulated the premarket approval process for lithotripters as a Class III device but reclassified lithotripters in 2000 to a Class II device. The corresponding guidance document for showing the substantial equivalence of new devices with predicate devices will be described in detail. The FDA guidance document is very useful in helping device manufacturers: (i) develop technical performance testing for a shock wave lithotripter within the parameters of an FDA submission, and (ii) conduct clinical performance testing via at least one clinical confirmation study with a small number of subjects. Unfortunately although the submitted data are available at the FDA they are not available in the marketplace and this causes difficulties for physicians in deciding which device to use. The results of the technical performance testing of the LithoGold™ are provided.

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...

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

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

PubMed

Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

2014-10-01

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

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

The role of the user within the medical device design and development process: medical device manufacturers' perspectives

PubMed Central

2011-01-01

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised. PMID:21356097

The Celution® System: Automated Processing of Adipose-Derived Regenerative Cells in a Functionally Closed System.

PubMed

Fraser, John K; Hicok, Kevin C; Shanahan, Rob; Zhu, Min; Miller, Scott; Arm, Douglas M

2014-01-01

Objective: To develop a closed, automated system that standardizes the processing of human adipose tissue to obtain and concentrate regenerative cells suitable for clinical treatment of thermal and radioactive burn wounds. Approach: A medical device was designed to automate processing of adipose tissue to obtain a clinical-grade cell output of stromal vascular cells that may be used immediately as a therapy for a number of conditions, including nonhealing wounds resulting from radiation damage. Results: The Celution ® System reliably and reproducibly generated adipose-derived regenerative cells (ADRCs) from tissue collected manually and from three commercial power-assisted liposuction devices. The entire process of introducing tissue into the system, tissue washing and proteolytic digestion, isolation and concentration of the nonadipocyte nucleated cell fraction, and return to the patient as a wound therapeutic, can be achieved in approximately 1.5 h. An alternative approach that applies ultrasound energy in place of enzymatic digestion demonstrates extremely poor efficiency cell extraction. Innovation: The Celution System is the first medical device validated and approved by multiple international regulatory authorities to generate autologous stromal vascular cells from adipose tissue that can be used in a real-time bedside manner. Conclusion: Initial preclinical and clinical studies using ADRCs obtained using the automated tissue processing Celution device described herein validate a safe and effective manner to obtain a promising novel cell-based treatment for wound healing.

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.

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.

US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.

PubMed

Lathrop, Julia Tait; Jeffery, Douglas A; Shea, Yvonne R; Scholl, Peter F; Chan, Maria M

2016-01-01

Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic. © 2015 American Association for Clinical Chemistry.

Electronic Voltage and Current Transformers Testing Device

PubMed Central

Pan, Feng; Chen, Ruimin; Xiao, Yong; Sun, Weiming

2012-01-01

A method for testing electronic instrument transformers is described, including electronic voltage and current transformers (EVTs, ECTs) with both analog and digital outputs. A testing device prototype is developed. It is based on digital signal processing of the signals that are measured at the secondary outputs of the tested transformer and the reference transformer when the same excitation signal is fed to their primaries. The test that estimates the performance of the prototype has been carried out at the National Centre for High Voltage Measurement and the prototype is approved for testing transformers with precision class up to 0.2 at the industrial frequency (50 Hz or 60 Hz). The device is suitable for on-site testing due to its high accuracy, simple structure and low-cost hardware. PMID:22368510

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...

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

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.

Rapid Globalization of Medical Device Clinical Development Programs in Japan　- The Case of Drug-Eluting Stents.

PubMed

Murakami, Madoka; Suzuki, Yuka; Tominaga, Toshiyoshi

2018-02-23

Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.

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...

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...

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 84.64 - Pretesting by applicant; approval of test methods.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 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...

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 84.64 - Pretesting by applicant; approval of test methods.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 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...

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

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 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...

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

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 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...

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...

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...

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 (...

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...

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.

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.

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. ...

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...

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...

The Celution® System: Automated Processing of Adipose-Derived Regenerative Cells in a Functionally Closed System

PubMed Central

Fraser, John K.; Hicok, Kevin C.; Shanahan, Rob; Zhu, Min; Miller, Scott; Arm, Douglas M.

2014-01-01

Objective: To develop a closed, automated system that standardizes the processing of human adipose tissue to obtain and concentrate regenerative cells suitable for clinical treatment of thermal and radioactive burn wounds. Approach: A medical device was designed to automate processing of adipose tissue to obtain a clinical-grade cell output of stromal vascular cells that may be used immediately as a therapy for a number of conditions, including nonhealing wounds resulting from radiation damage. Results: The Celution® System reliably and reproducibly generated adipose-derived regenerative cells (ADRCs) from tissue collected manually and from three commercial power-assisted liposuction devices. The entire process of introducing tissue into the system, tissue washing and proteolytic digestion, isolation and concentration of the nonadipocyte nucleated cell fraction, and return to the patient as a wound therapeutic, can be achieved in approximately 1.5 h. An alternative approach that applies ultrasound energy in place of enzymatic digestion demonstrates extremely poor efficiency cell extraction. Innovation: The Celution System is the first medical device validated and approved by multiple international regulatory authorities to generate autologous stromal vascular cells from adipose tissue that can be used in a real-time bedside manner. Conclusion: Initial preclinical and clinical studies using ADRCs obtained using the automated tissue processing Celution device described herein validate a safe and effective manner to obtain a promising novel cell-based treatment for wound healing. PMID:24761343

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...

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...

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...

Protecting computer-based medical devices: defending against viruses and other threats.

PubMed

2005-07-01

The increasing integration of computer hardware has exposed medical devices to greater risks than ever before. More and more devices rely on commercial off-the-shelf software and operating systems, which are vulnerable to the increasing proliferation of viruses and other malicious programs that target computers. Therefore, it is necessary for hospitals to take steps such as those outlined in this article to ensure that their computer-based devices are made safe and continue to remain safe in the future. Maintaining the security of medical devices requires planning, careful execution, and a commitment of resources. A team should be created to develop a process for surveying the security status of all computerized devices in the hospital and making sure that patches and other updates are applied as needed. These patches and updates should be approved by the medical system supplier before being implemented. The team should consider using virtual local area networks to isolate susceptible devices on the hospital's network. All security measures should be carefully documented, and the documentation should be kept up-to-date. Above all, care must be taken to ensure that medical device security involves a collaborative, supportive partnership between the hospital's information technology staff and biomedical engineering personnel.

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...

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

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...

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.

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...

Ultra-low-cost clinical pulse oximetry.

PubMed

Petersen, Christian L; Gan, Heng; MacInnis, Martin J; Dumont, Guy A; Ansermino, J Mark

2013-01-01

An ultra-low-cost pulse oximeter is presented that interfaces a conventional clinical finger sensor with a mobile phone through the headset jack audio interface. All signal processing is performed using the audio subsystem of the phone. In a preliminary volunteer study in a hypoxia chamber, we compared the oxygen saturation obtained with the audio pulse oximeter against a commercially available (and FDA approved) reference pulse oximeter (Nonin Xpod). Good agreement was found between the outputs of the two devices.

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...

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...

Tumor treating fields - an emerging cancer treatment modality.

PubMed

Davis, Mary Elizabeth

2013-08-01

Tumor treating fields (TTFs) are an evolving new anticancer modality. The U.S. Food and Drug Administration has approved the first device, the NovoTTF-100A™, that uses this technology and is indicated for use in progressive glioblastoma multiforme after standard therapies have failed. Promising clinical trial results will likely lead to expanded uses in primary brain tumors and other cancer types. This article will review the concept of TTFs and their mechanism of action, and overview the TTF device and its approved usage.

Analysis of the Education Program Approval Process: A Program Evaluation.

ERIC Educational Resources Information Center

Fountaine, Charles A.; And Others

A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

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.

21 CFR 814.104 - Original applications.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Emulating Industrial Control System Field Devices Using Gumstix Technology

DTIC Science & Technology

2012-06-01

EMULATING INDUSTRIAL CONTROL SYSTEM FIELD DEVICES USING GUMSTIX TECHNOLOGY THESIS Dustin J...APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED. The views expressed in this thesis are those of the...EMULATING INDUSTRIAL CONTROL SYSTEM FIELD DEVICES USING GUMSTIX TECHNOLOGY THESIS Presented to the Faculty Department of

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

PubMed Central

Alving, K; Janson, C; Nordvall, L

2006-01-01

Background 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). Methods 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). Results Success rate was high (≥ 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. Conclusion 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. PMID:16626491

High energy devices versus low energy devices in orthopedics treatment modalities

NASA Astrophysics Data System (ADS)

Schultheiss, Reiner

2003-10-01

The orthopedic consensus group defined in 1997 the 42 most likely relevant parameters of orthopedic shock wave devices. The idea of this approach was to correlate the different clinical outcomes with the physical properties of the different devices with respect to their acoustical waves. Several changes in the hypothesis of the dose effect relationship have been noticed since the first orthopedic treatments. The relation started with the maximum pressure p+, followed by the total energy, the energy density; and finally the single treatment approach using high, and then the multiple treatment method using low energy. Motivated by the reimbursement situation in Germany some manufacturers began to redefine high and low energy devices independent of the treatment modality. The OssaTron as a high energy, single treatment electro hydraulic device gained FDA approval as the first orthopedic ESWT device for plantar fasciitis and, more recently, for lateral epicondylitis. Two low energy devices have now also gained FDA approval based upon a single treatment. Comparing the acoustic data, differences between the OssaTron and the other devices are obvious and will be elaborated upon. Cluster analysis of the outcomes and the acoustical data are presented and new concepts will be suggested.

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...

21 CFR 814.100 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

49 CFR 175.9 - Exceptions for special aircraft operations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... parachute operation. (c) Smoke grenades, flares, and pyrotechnic devices affixed to aircraft during any... the smoke grenades, flares, or pyrotechnic devices on the aircraft must be approved for its intended...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

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...

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2011 CFR

2011-04-01

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

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Personal Area Networks in Tactical Mobile Devices

DTIC Science & Technology

2014-08-01

TECHNICAL DOCUMENT 2047 August 2014 Personal Area Networks in Tactical Mobile Devices Brian Visser...Tactical Mobile Devices Brian Visser Approved for public release. SSC Pacific San Diego, CA 92152-5001 SB...consistent power source, which is normally not available to patrols. In addition to the lack of computer resources, robust network infrastructure

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, 2010 CFR

2010-07-01

... be used in Subcategory I-C mines. (c)(1) If electrically powered, remote sensing devices are used.... (2) If air samples are delivered to remote analytical devices through sampling tubes, such tubes...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

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

The development of neural stimulators: a review of preclinical safety and efficacy studies.

PubMed

Shepherd, Robert K; Villalobos, Joel; Burns, Owen; Nayagam, David

2018-05-14

Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of several key components in the development pathway from concept to product release of neural stimulators. Importantly, these studies provide iterative feedback in order to optimise the final design of the device. Key components of any preclinical evaluation include: in vitro studies that are focussed on device reliability and include accelerated testing under highly controlled environments; in vivo studies using animal models of the disease or injury in order to assess safety and, given an appropriate animal model, the efficacy of the technology under both passive and electrically active conditions; and human cadaver and ex vivo studies designed to ensure the device's form factor conforms to human anatomy, to optimise the surgical approach and to develop any specialist surgical tooling required. The pipeline from concept to commercialisation of these devices is long and expensive; careful attention to both device design and its preclinical evaluation will have significant impact on the duration and cost associated with taking a device through to commercialisation. Carefully controlled in vitro and in vivo studies together with ex vivo and human cadaver trials are key components of a thorough preclinical evaluation of any new neural stimulator. © 2018 IOP Publishing Ltd.

42 CFR 84.142 - Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators...

Code of Federal Regulations, 2014 CFR

2014-10-01

... RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air Respirators § 84... multiple systems, whereby more than one user is supplied by one blower, will be approved, unless each hose...

42 CFR 84.142 - Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators...

Code of Federal Regulations, 2013 CFR

2013-10-01

... RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air Respirators § 84... multiple systems, whereby more than one user is supplied by one blower, will be approved, unless each hose...

42 CFR 84.142 - Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators...

Code of Federal Regulations, 2010 CFR

2010-10-01

... RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air Respirators § 84... multiple systems, whereby more than one user is supplied by one blower, will be approved, unless each hose...

42 CFR 84.142 - Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators...

Code of Federal Regulations, 2012 CFR

2012-10-01

... RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air Respirators § 84... multiple systems, whereby more than one user is supplied by one blower, will be approved, unless each hose...

42 CFR 84.142 - Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators...

Code of Federal Regulations, 2011 CFR

2011-10-01

... RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air Respirators § 84... multiple systems, whereby more than one user is supplied by one blower, will be approved, unless each hose...

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.

78 FR 49412 - Personal Flotation Devices Labeling and Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

...The Coast Guard proposes to remove references to type codes in its regulations on the carriage and labeling of Coast Guard-approved personal flotation devices (PFDs). PFD type codes are unique to Coast Guard approval and are not well understood by the public. Removing these type codes from our regulations would facilitate future incorporation by reference of new industry consensus standards for PFD labeling that will more effectively convey safety information, and is a step toward harmonization of our regulations with PFD requirements in Canada and in other countries.

Evaluation of high mast luminaire lowering devices in Oregon.

DOT National Transportation Integrated Search

1981-09-01

High mast luminaire lowering devices were installed on two projects in Oregon following approval by the Department of Transportation, Federal Highway Administration, of the installations as experimental features projects. Holophane Company, Inc., sup...

77 FR 22384 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... passive, microprocessor-based device which includes a starter interrupt function, transponder key and a.... Porsche stated that the antitheft system consists of two major subsystems: a microprocessor-based...

75 FR 22174 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

... passive antitheft device installed on the Porsche Panamera includes a microprocessor-based immobilizer... modified antitheft system will now consist of a microprocessor based immobilizer system which prevents...

Improving medical device regulation: the United States and Europe in perspective.

PubMed

Sorenson, Corinna; Drummond, Michael

2014-03-01

Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices. © 2014 Milbank Memorial Fund.

Improving Medical Device Regulation: The United States and Europe in Perspective

PubMed Central

SORENSON, CORINNA; DRUMMOND, MICHAEL

2014-01-01

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre-and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium-and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices. PMID:24597558

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

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

75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-06

... to Amend FINRA Rule 8210 to Require Information Provided via Portable Media Device be Encrypted... to require that information provided via a portable media device pursuant to a request under the rule..., persons often provide information in electronic format using a portable media device such as a CD-ROM, DVD...

75 FR 52294 - Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-25

... Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the... could lead to potentially debilitating or fatal thromboembolism. b. Excessive hemolysis--poor design of the hemodynamic characteristics of the device can lead to excess hemolysis. c. Inability to support...

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...

Innovations in Bariatric Surgery.

PubMed

Zhu, Catherine; Pryor, Aurora D

2015-11-01

Surgery has consistently been demonstrated to be the most effective long-term therapy for the treatment of obesity. However, despite excellent outcomes with current procedures, most patients with obesity- and weight-related comorbidities who meet criteria for surgical treatment choose not to pursue surgery out of fear of operative risks and complications or concerns about high costs. Novel minimally invasive procedures and devices may offer alternative solutions for patients who are hesitant to pursue standard surgical approaches. These procedures may be used for primary treatment of obesity, early intervention for patients approaching morbid obesity, temporary management prior to bariatric surgery, or revision of bypass surgery associated with weight regain. Novel bariatric procedures can in general be divided into four categories: endoluminal space-occupying devices, gastric suturing and restrictive devices, absorption-limiting devices, and neural-hormonal modulating devices. Many of these are only approved as short-term interventions, but these devices may be effective for patients desiring low-risk procedures or a transient effect. We will see the expansion of indications and alternatives for metabolic surgery as these techniques gain approval.

Design control considerations for biologic-device combination products.

PubMed

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting development of innovative, safe and effective combination products. It remains the manufacturer's responsibility to comply with the relevant requirements and regulations, and develop good business practices that clearly describe how these practices comply with FDA's final rule (21 CFR Part 4) and aligns with the company's already established quality system. Copyright © 2017 Elsevier B.V. All rights reserved.

[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.

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

PubMed

Fraser, Alan G; Daubert, Jean-Claude; Van de Werf, Frans; Estes, N A Mark; Smith, Sidney C; Krucoff, Mitchell W; Vardas, Panos E; Komajda, Michel

2011-07-01

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

76 FR 19100 - Maria Carmen Palazzo: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-06

... development or approval, including the process for development or approval, of any drug product or otherwise... development or approval, including the process for development or approval, of any drug product or otherwise... approval, including the process for development or approval, of any drug product and otherwise relating to...

77 FR 47491 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-08

... Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Flight Simulation... simulation training. DATES: Written comments should be submitted by September 7, 2012. FOR FURTHER... INFORMATION: OMB Control Number: 2120-0680. Title: Flight Simulation Device Initial and Continuing...

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...

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...

Lessons from innovation in drug-device combination products.

PubMed

Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

2012-01-01

Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon. Copyright © 2011 Elsevier B.V. All rights reserved.

Evolution and update on current devices for prosthetic breast reconstruction

PubMed Central

2015-01-01

Over the past decade, the leading breast reconstruction modality has shifted from autologous tissue to implants. This trend reversal is multi-factorial but includes increasing bilateral mastectomies and the more widespread acceptance of implants due to stringent quality and safety regulatory surveillance by the US Food and Drug Administration (FDA). Since 2012, the US FDA has approved several new implant styles, shapes and textures, increasing the choices for patients and surgeons. Predictable, superior aesthetic results after prosthetic breast reconstruction are attainable, but require thoughtful planning, precise surgical technique and appropriate device selection based on several different patient and surgeon parameters, such as patient desires, body mass index, breast shape, mastectomy flap quality and tissue based bio-dimensional assessment. This article briefly reviews historic devices used in prosthetic breast reconstruction beginning in the 1960s through the modern generation devices used today. We reflect on the rigorous hurdles endured over the last several decades leading to the approval of silicone gel devices, along with their well-established safety and efficacy. The various implant characteristics can affect feel and performance of the device. The many different styles and features of implants and expanders are described emphasizing surgical indications, advantages and disadvantages of each device. PMID:26005642

49 CFR Appendix A to Part 221 - Procedures for Approval of Rear End Marking Devices

Code of Federal Regulations, 2011 CFR

2011-10-01

... description of the device including the type, luminance description, size of lens, manufacturer and catalog number, lamp manufacturer, lamp type and model number, and any auxiliary optics used. (2) A certification...

49 CFR Appendix A to Part 221 - Procedures for Approval of Rear End Marking Devices

Code of Federal Regulations, 2010 CFR

2010-10-01

... description of the device including the type, luminance description, size of lens, manufacturer and catalog number, lamp manufacturer, lamp type and model number, and any auxiliary optics used. (2) A certification...

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...

HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT FOR THE ADOPTION OF INNOVATIVE MEDICAL DEVICES WITHIN FRENCH HOSPITALS: OPPORTUNITIES AND CHALLENGES FOR INDUSTRY.

PubMed

Dutot, Camille; Mercier, Grégoire; Borget, Isabelle; de Sauvebeuf, Côme; Martelli, Nicolas

2017-01-01

Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers' insights into Hb-HTA processes. A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers' market access strategies was administered. Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity. Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.

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

77 FR 29748 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

... Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Flight Simulation... obtained and maintained by those who conduct flight simulation training. DATES: Written comments should be... Simulation Device Initial and Continuing Qualification and Use. Form Numbers: There are no FAA forms...

9 CFR 317.4 - Labeling approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Devices, except for generically approved labeling authorized for use in § 317.5(b). The management of the... indication of final color, as specified in § 317.2. FSIS will accept sketches that are hand drawn, computer generated or other reasonable facsimiles that clearly reflect and project the final version of the labeling...

76 FR 17136 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d......... Dako Denmark A/S..... HercepTest kit Approved October 20, 2010. P080009 Ethicon Endo-Surgery, SEDASYS...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

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

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...

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 84.32 - Notice of disapproval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Notice of disapproval. 84.32 Section 84.32 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 Disapproval § 84.32...

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 84.32 - Notice of disapproval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Notice of disapproval. 84.32 Section 84.32 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 Disapproval § 84.32...

42 CFR 84.32 - Notice of disapproval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Notice of disapproval. 84.32 Section 84.32 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 Disapproval § 84.32...

42 CFR 84.32 - Notice of disapproval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Notice of disapproval. 84.32 Section 84.32 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 Disapproval § 84.32...

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...

42 CFR 84.32 - Notice of disapproval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Notice of disapproval. 84.32 Section 84.32 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 Disapproval § 84.32...

Barriers to investigator-initiated deep brain stimulation and device research

PubMed Central

Malone, Donald; Okun, Michael S.; Booth, Joan; Machado, Andre G.

2014-01-01

The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. However, both the structure of clinical trial funding and the current regulation of device research threaten investigator-initiated efforts in neurologic disorders. The current atmosphere dissuades clinical investigators from pursuing formal and prospective research with novel devices or novel indications. We review our experience in conducting a federally funded, investigator-initiated, device-based clinical trial that utilized DBS for thalamic pain syndrome. We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients. PMID:24670888

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...

77 FR 1768 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-11

... Held Device--Opening and Closing Order Imbalances Only (Together the ``Hand Held Device Fees''), the... the NYSE e-Broker[supreg] Hand Held Device--Opening and Closing Order Imbalances Only (together the... Imbalances Only, the $1,000 per year fee for approval of a pre-qualified substitute, and the $250 per year...

24 CFR 3280.404 - Standard for egress windows and devices for use in manufactured homes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Standard for egress windows and... SAFETY STANDARDS Testing § 3280.404 Standard for egress windows and devices for use in manufactured homes..., construction, and installation of windows and approved devices intended to be used as an emergency exit during...

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... performed to assure that the sampling devices are clean and in proper working condition by a person... voltage per cell value; (2) Examination of all components of the cyclone to assure that they are clean and... sampling device to assure that it is clean and free of leaks; and (5) Examination of the clamping and...

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... performed to assure that the sampling devices are clean and in proper working condition by a person... voltage per cell value; (2) Examination of all components of the cyclone to assure that they are clean and... sampling device to assure that it is clean and free of leaks; and (5) Examination of the clamping and...

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... performed to assure that the sampling devices are clean and in proper working condition by a person... voltage per cell value; (2) Examination of all components of the cyclone to assure that they are clean and... sampling device to assure that it is clean and free of leaks; and (5) Examination of the clamping and...

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

PubMed Central

Faunce, Thomas Alured

2006-01-01

• Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations. PMID:16569240

78 FR 20268 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-04

... methods: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking... effectiveness of the device but does not include descriptions of methods of manufacture or product composition... scientific literature [[Page 20272

42 CFR 405.209 - Payment for a non-experimental/investigational (Category B) device.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Medical Services Coverage Decisions That Relate to Health Care Technology § 405.209 Payment for a non... used device serving the same medical purpose that has been approved or cleared for marketing by the FDA. ...

Cathodoluminescence Characterization of Ion Implanted GaAs.

DTIC Science & Technology

1980-03-01

technique that can be used to characterize the semiconductor device "in situ" before further processing can save the Air Force valuable time as well...Patterson Air Force Base,Ohio i! i ill i I ;Wow AFIT/DS/PH/80- I.i1I LEVELOO CATHODOLUMINESCENCE CHARACTERIZATION OF ION IPLANTED GaAs D I SSERUrAT ION...CATODOLUMINESCENCE CHARACTERIZATION .’ a .... OF ION IMPLANTED GaAs’ - .. .. Dtriy’ t’ c:’/ A’: t 1. - Cc;-,P by an i’or Milton L one B.S., M.S. Major USAF Approved

Recent developments in photonic networking components for space applications

NASA Astrophysics Data System (ADS)

Parkerson, James P.; Gorman, Lanitia; Thamer, Robert; Chalfant, Charles H.; Hull, Anthony; Orlando, Fred J., Jr.

2003-07-01

Industrial, NASA, and DoD spacecraft designers have recognized the advantages of using fiber optic components and networks for their internal satellite data handling needs. Among the benefits are the total elimination of cable-to-cable and box-to-box EMI; significant size, weight and power reduction; greater on-orbit and integration and test flexibility and significantly lower integration and test costs. Additionally, intra-satellite data rates of 1 to 10 Gbps appear to be an absolute requirement for a number of advanced systems planned for development in the next few years. The only practical way to support these data rates is with fiber optics. Space Photonics and the University of Arkansas have developed fiber optic components (FireFiberTM) and networks that are designed specifically to meet these on-board, high data rate needs using NASA approved materials, packaging processes, and approved radiation tolerant devices. This paper will discuss recent developments in photonic components for spaceborne networks.

Photonic packaging for space applications

NASA Astrophysics Data System (ADS)

Parkerson, James P.; Chalfant, Charles H., III; Orlando, Fred J., Jr.; Hull, Tony

2002-07-01

Industrial, NASA, and DOD spacecraft designers have recognized the advantages of using fiber optic components and networks for their internal satellite data handling needs. Among the benefits are the total elimination of cable-to-cable and box-to-box EMI; significant size, weight and power reduction; greater on-orbit flexibility, simplified integration and test (I&T), and significantly lower I&T costs. Additionally, intra-satellite data rates of 1 to 10 Gbps appear to be an absolute requirement for a number of advanced systems planned for development in the next few years. The only practical way to support these data rates is with fiber optics. Space Photonics and the University of Arkansas have developed fiber optic components (FireFiberTM) and networks that are designed specifically to meet these on-board, high data rate needs using NASA approved materials, packaging processes, and approved radiation tolerant devices. This paper discusses issues relevant to these components and networks.

46 CFR 180.72 - Personal flotation devices carried in addition to life jackets.

Code of Federal Regulations, 2014 CFR

2014-10-01

... emergencies. (b) Wearable marine buoyant devices that include “ski vests,” “boating vests,” and “fishing vests... Commandant, may be carried as additional equipment. (c) Buoyant work vests approved in accordance with § 160...

46 CFR 180.72 - Personal flotation devices carried in addition to life jackets.

Code of Federal Regulations, 2013 CFR

2013-10-01

... emergencies. (b) Wearable marine buoyant devices that include “ski vests,” “boating vests,” and “fishing vests... Commandant, may be carried as additional equipment. (c) Buoyant work vests approved in accordance with § 160...

46 CFR 180.72 - Personal flotation devices carried in addition to life jackets.

Code of Federal Regulations, 2012 CFR

2012-10-01

... emergencies. (b) Wearable marine buoyant devices that include “ski vests,” “boating vests,” and “fishing vests... Commandant, may be carried as additional equipment. (c) Buoyant work vests approved in accordance with § 160...

A strategy for measuring patient preferences to incorporate in benefit-risk assessment of new ophthalmic devices and procedures

NASA Astrophysics Data System (ADS)

Massof, R. W.; Bradley, C.

2016-11-01

The U.S. Food and Drug Administration recently released guidance documents explaining that measurement of patient preferences should be considered during the pre-market approval process to specify patients’ tolerances for risk and perspectives on benefit when assessing the benefit-risk profile of new medical devices. For ophthalmological patients, the typical primary clinical outcome is a visual impairment measure. Especially for surgically- implanted devices, the benefit a specified improvement in vision measures must be translated to a patient-specific benefit of the improvement in ability to function in everyday life. We developed, and validated with simulations, a strategy for measuring an individual patient's ability to function and the overall benefit to that patient of specified improvements in functional ability. Our strategy employs Rasch analysis to measure changes in functional ability; multidimensional scaling to measure patient-specific benefits of changes in functional ability; and structural equation modeling to cross-walk patient preferences for functional ability changes to changes in visual impairment measures.

What is the Process Approvals for Survey Research in the Department of Defense (DoD)

DTIC Science & Technology

2017-04-26

MDW/SGVU SUBJECT: Professional Presentation Approval 11APR 2017 1. Your paper, entitled What is the Process? Approvals for Survey Research in the...approval.) NA 6. TITLE OF MATERIAL TO BE PUBLISHED OR PRESENTED: What is the Process? Approvals for Survey Research in the Department of Defense (DoD...PREVIOUS EDITIONS ARE OBSOLETE 50. DATE I Page 3 of 3 Pages W_hat is the process? Approval of Survey Research in the Department of Defense (DoD

21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.

Code of Federal Regulations, 2010 CFR

2010-04-01

... contains an untrue statement of material fact, or omits material information; (5) The device's labeling... in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason... conducting the study and the good laboratory practice regulations do not support the validity of the study...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

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

76 FR 4653 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... Activities; Submission to OMB for Review and Approval; Comment Request; Recordkeeping Requirements for... Insecticide, Fungicide, and Rodenticide Act (FIFRA); EPA ICR No. 0143.11, OMB Control No. 2070-0028 AGENCY... Devices Under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). ICR numbers...

21 CFR 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

Code of Federal Regulations, 2014 CFR

2014-04-01

... surveillance plan has been approved? 822.25 Section 822.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.25 What are my responsibilities after my postmarket surveillance plan has been...

21 CFR 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

Code of Federal Regulations, 2011 CFR

2011-04-01

... surveillance plan has been approved? 822.25 Section 822.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.25 What are my responsibilities after my postmarket surveillance plan has been...

21 CFR 822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?

Code of Federal Regulations, 2010 CFR

2010-04-01

... surveillance plan has been approved? 822.25 Section 822.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.25 What are my responsibilities after my postmarket surveillance plan has been...

21 CFR 814.84 - Reports.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Reports. 814.84 Section 814.84 Food and Drugs FOOD... APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA... otherwise, any periodic report shall: (1) Identify changes described in § 814.39(a) and changes required to...

21 CFR 814.84 - Reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Reports. 814.84 Section 814.84 Food and Drugs FOOD... APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.84 Reports. (a) The holder of an approved PMA... otherwise, any periodic report shall: (1) Identify changes described in § 814.39(a) and changes required to...

Vat rates on medical devices: foreign experience and Ukrainian practice.

PubMed

Pashkov, Vitalii; Hutorova, Nataliia; Harkusha, Andrii

2017-01-01

In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.

Delivery of inhaled drugs for infants and small children: a commentary on present and future needs.

PubMed

Fink, James B

2012-11-01

Although the manufacture of inhaled medications is a multibillion dollar industry, virtually no pharmaceutical drug/device combination has been approved for inhalation across the range of pediatric patient ages and sizes. The clinician who treats neonates, infants, or toddlers is often faced with the dilemma of prescribing inhaled medications that may be disease appropriate but have not been approved for use in patients in these age categories. Their use is thus technically "off label," with limited empirical data to guide both dose and device selection. This dilemma requires the prescribing physician to go beyond the limitations of the product label, often without benefit of appropriately designed clinical trials, in an attempt to select safe and effective doses for use with these smallest of patients. The vast majority of drugs approved for inhalation were studied by using aerosol devices designed for older children and adults using a mouthpiece interface, which may not be practical for use in infants and patients aged <4 years. The selection of the most age-appropriate device and interface is critical for the effective administration of the prescribed therapy. In the absence of industry-sponsored clinical trials in neonates, infants, and toddlers, in vitro and in vivo strategies may help guide age-appropriate dosing, device, and interface selection to better inform clinical practice. In this commentary, the challenges in developing and prescribing effective formulations for aerosol delivery across the range of pediatric ages and sizes are explored, with guidance for device and interface selection. Recommendations for future collaborative sharing of in vitro models and age-specific breathing patterns between academic and industry researchers could help regulators and clinicians better understand the impact age and size have on pulmonary drug delivery. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

40 CFR 63.4767 - How do I establish the emission capture system and add-on control device operating limits during...

Code of Federal Regulations, 2013 CFR

2013-07-01

... system and add-on control device operating limits during the performance test? 63.4767 Section 63.4767... system and add-on control device operating limits during the performance test? During the performance... operating limits required by § 63.4692 according to this section, unless you have received approval for...

40 CFR 63.4167 - How do I establish the emission capture system and add-on control device operating limits during...

Code of Federal Regulations, 2012 CFR

2012-07-01

... capture system and add-on control device operating limits during the performance test? 63.4167 Section 63... capture system and add-on control device operating limits during the performance test? During the... the operating limits required by § 63.4092 according to this section unless you have received approval...

40 CFR 63.4167 - How do I establish the emission capture system and add-on control device operating limits during...

Code of Federal Regulations, 2014 CFR

2014-07-01

... capture system and add-on control device operating limits during the performance test? 63.4167 Section 63... capture system and add-on control device operating limits during the performance test? During the... the operating limits required by § 63.4092 according to this section unless you have received approval...

Semaglutide: First Global Approval.

PubMed

Dhillon, Sohita

2018-02-01

Novo Nordisk has developed a subcutaneous formulation of semaglutide (Ozempic ® ), a modified human glucagon-like peptide-1 (GLP-1) analogue, for the treatment of type 2 diabetes mellitus. It has been developed using Novo Nordisk's proprietary protein-acylation technology, and is administered using an injection device. Semaglutide lowers blood glucose by stimulating the release of insulin and also lowers body weight. Once-weekly subcutaneous semaglutide has recently been approved in the US, Puerto Rico and Canada, and has received a positive opinion in the EU for the treatment of patients with type 2 diabetes. It will be launched as the Ozempic ® Pen, a pre-filled device. Semaglutide is also under regulatory review in Japan and Switzerland for the treatment of type 2 diabetes. Clinical development for obesity, non-alcoholic steatohepatitis and non-alcoholic fatty liver disease is underway worldwide. This article summarizes the milestones in the development of semaglutide leading to this first approval for type 2 diabetes.

10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

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...

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

PubMed

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

2016-01-01

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

Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.

PubMed

Walter, Jessica R; Ghobadi, Comeron W; Hayman, Emily; Xu, Shuai

2017-01-01

In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

77 FR 38019 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: TRICARE Retail...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-26

... prescriptions approved through the non-formulary special approval process that validates the medical necessity... the process for formulary placement of newly approved drugs; streamline the process for updating... clarify the process for formulary placement of newly approved drugs by the Food and Drug Administration...

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

PubMed

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

PR Notice 94-4 MOU on Regulation of Liquid Chemical Germicides Intended for Use on Medical Devices

EPA Pesticide Factsheets

This MOU between EPA and FDA establishes roles for regulation of liquid chemical germicides intended for use on medical devices. An amendment revises the disclaimer statement for labels of all liquid chemical germicides, other than FDA-approved sterilants.

75 FR 50036 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Ford Motor Company

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... standard equipment or the optional Intelligent Access with Push Button Start (IAwPB). Key components of the... and reports back to the BCM whether a valid key was found. In both devices, if the codes do not match...

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

30 CFR 70.100 - Respirable dust standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... mine atmosphere during each shift to which each miner in the active workings of each mine is exposed at... sampling device and in terms of an equivalent concentration determined in accordance with § 70.206 (Approved sampling devices; equivalent concentrations). (b) Each operator shall continuously maintain the...

46 CFR 38.15-15 - Electrical installations-TB/ALL.

Code of Federal Regulations, 2014 CFR

2014-10-01

... this chapter for tank vessels, except as otherwise specified in this part. (b) Spaces containing cargo... devices, except Coast Guard approved intrinsically safe devices, shall be installed in these spaces. Electric motors shall be segregated from these spaces by a gastight bulkhead. Electric lighting of the...

46 CFR 38.15-15 - Electrical installations-TB/ALL.

Code of Federal Regulations, 2012 CFR

2012-10-01

... this chapter for tank vessels, except as otherwise specified in this part. (b) Spaces containing cargo... devices, except Coast Guard approved intrinsically safe devices, shall be installed in these spaces. Electric motors shall be segregated from these spaces by a gastight bulkhead. Electric lighting of the...

46 CFR 38.15-15 - Electrical installations-TB/ALL.

Code of Federal Regulations, 2010 CFR

2010-10-01

... this chapter for tank vessels, except as otherwise specified in this part. (b) Spaces containing cargo... devices, except Coast Guard approved intrinsically safe devices, shall be installed in these spaces. Electric motors shall be segregated from these spaces by a gastight bulkhead. Electric lighting of the...

46 CFR 38.15-15 - Electrical installations-TB/ALL.

Code of Federal Regulations, 2011 CFR

2011-10-01

... this chapter for tank vessels, except as otherwise specified in this part. (b) Spaces containing cargo... devices, except Coast Guard approved intrinsically safe devices, shall be installed in these spaces. Electric motors shall be segregated from these spaces by a gastight bulkhead. Electric lighting of the...

46 CFR 38.15-15 - Electrical installations-TB/ALL.

Code of Federal Regulations, 2013 CFR

2013-10-01

... this chapter for tank vessels, except as otherwise specified in this part. (b) Spaces containing cargo... devices, except Coast Guard approved intrinsically safe devices, shall be installed in these spaces. Electric motors shall be segregated from these spaces by a gastight bulkhead. Electric lighting of the...

40 CFR 86.1 - Incorporation by reference.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Docket and Information Center, 1301 Constitution Ave., NW., Room B102, EPA West Building, Washington, DC... inspection at the National Archives and Records Administration (NARA). For information on the availability of... Control Devices, Article 2 Approval of Motor Vehicle Pollution Control Devices (New Vehicles), § 1961.2...

44 CFR 78.6 - Flood Mitigation Plan approval process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... approval process. 78.6 Section 78.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY... MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all Flood... reasons for non-approval and offer suggestions for improvement. ...

Nitinol Temperature Monitoring Devices

DTIC Science & Technology

1976-01-09

AD-A021 578 NITINOL TEMPERATURE MONITORING DEVICES William J. Buehler, et al Naval Surface Weapons Center Silver Spring, Maryland 9 January 1976...LABORATORY S NITINOL TEMPERATURE MONITORING DEVICES 9 JANUARY 1976 NAVAL SURFACE WEAPONS CENTER WHITE OAK LABORATORY SILVER SPRING, MARYLAND 20910 * Approved...GOVT ACCESSION NO. 3. RECIPIIENT’S CATALOG NUMBER NSWC/WOL/TR 75-140 ____ ______ 4 TITLE (and Subtitle) 5. TYPE OF REPCRT & PERIOD COVERED Nitinol

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...

Military Hearing Conservation Workshop Director Handbook,

DTIC Science & Technology

1983-11-01

r HaigCnerainDrctrHnbo (b*T scp -asgnetsorrspniblt.s -:.--3 .’..................................................................an. HSHB-OB November...Approved Hearing Protective Devices and Related Equipment. a. Nonstandard. (NOT APPROVED). (I) Fingers (bi-digital earplugs). - - (2) Palms . (3...a) Single-flange (5-10 percent have different sizes between ears): () extra small (white) - 5 percent (ii) small (green) - 25 percent . oil . 5-26 9

30 CFR 71.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... voltage per cell value; (2) Examination of all 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... positioning of the cyclone body, vortex finder and cassette to assure that they are rigid, in alignment, and...

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... voltage per cell value; (2) Examination of all 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... positioning of the cyclone body, vortex finder and cassette to assure that they are rigid, in alignment, and...

30 CFR 71.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... voltage per cell value; (2) Examination of all 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... positioning of the cyclone body, vortex finder and cassette to assure that they are rigid, in alignment, and...