Medical Devices Fda Should Enhance Its Oversight Of Recalls

Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 57 pages
File Size : 52,8 Mb
Release : 2011
Category : Medical
ISBN : 9781437988062

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Medical Devices: FDA Should Enhance Its Oversight of Recalls by Marcia Crosse Pdf

Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies: (1) the numbers and characteristics of medical device recalls and FDA's use of this info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.

Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 58 pages
File Size : 51,9 Mb
Release : 2018-01-08
Category : Electronic
ISBN : 1983616834

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Medical Devices by United States Government Accountability Office Pdf

Medical Devices: FDA Should Enhance Its Oversight of Recalls

Author : United States. General Accounting Office
Publisher : Unknown
Page : 42 pages
File Size : 48,5 Mb
Release : 1998
Category : Medical instruments and apparatus
ISBN : UOM:39015047858876

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Medical Devices by United States. General Accounting Office Pdf

Author : United States Accounting Office (GAO)
Publisher : Createspace Independent Publishing Platform
Page : 38 pages
File Size : 55,8 Mb
Release : 2018-02-07
Category : Electronic
ISBN : 1984325817

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Hehs-98-211 Medical Devices by United States Accounting Office (GAO) Pdf

HEHS-98-211 Medical Devices: FDA Can Improve Oversight of Tracking and Recall Systems

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 54,8 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458

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Medical Devices and the Public's Health by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher : Unknown
Page : 1026 pages
File Size : 42,9 Mb
Release : 2017
Category : United States
ISBN : IND:30000159714405

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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2018 by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Pdf

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 132 pages
File Size : 51,8 Mb
Release : 2011-06-10
Category : Medical
ISBN : 9780309162067

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher : Unknown
Page : 1548 pages
File Size : 51,9 Mb
Release : 2006
Category : Political Science
ISBN : MINN:31951D02533404J

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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2003: Agricultural programs by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Pdf

Author : Anonim
Publisher : DIANE Publishing
Page : 22 pages
File Size : 47,9 Mb
Release : 2024-07-03
Category : Electronic
ISBN : 9781437984507

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Medical Devices: FDA’s Premarket Review and Postmarket Safety Efforts: Testimony Before the Special Committee on Aging, U.S. Senate by Anonim Pdf

Author : Kevin L. Ong,Scott Lovald,Jonathan Black
Publisher : CRC Press
Page : 466 pages
File Size : 49,5 Mb
Release : 2014-02-21
Category : Medical
ISBN : 9781466503502

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Orthopaedic Biomaterials in Research and Practice, Second Edition by Kevin L. Ong,Scott Lovald,Jonathan Black Pdf

Revised, expanded, and updated, Orthopaedic Biomaterials in Research and Practice, Second Edition introduces materials science and applies it to medical research and treatment. This book incorporates math and engineering, which makes it accessible to trainees and others working in the industry who are lacking primary mathematical and engineering training. What’s New in the Second Edition: In the second edition, the new material includes regeneration, hybrid and replant materials, tissue engineering, electrical stimulation for tissue growth and repair, modeling of material behavior in service, and long-term function of materials in patients. It explores tools for non-destructive and destructive analysis of explanted devices, and provides updates on all material classes including shape memory and degradable alloys, fracture-resistant ceramics, and bioabsorbable polymers. It provides a compendium for implant host response including in-depth discussion of metallosis and hypersensitive response. It also adds new case studies, worked problems, and a complete self-evaluation test with annotated answers. Includes focused, practical study questions after each chapter Presents extensive, detailed figures accompanying example problems and concepts Provides a one-stop reference for understanding all biomaterials that are used in contemporary orthopaedic surgery and beyond Introduces key concepts of relevance in each chapter Orthopaedic Biomaterials in Research and Practice, Second Edition serves as a textbook for orthopaedic residents. It can also serve as a review for the Orthopaedists In-Training Examination (OITE), the Orthopaedic Self-Assessment Examination, or the Orthopaedic Board Examination.

Author : Lawton R. Burns
Publisher : Cambridge University Press
Page : 607 pages
File Size : 43,7 Mb
Release : 2012-07-26
Category : Business & Economics
ISBN : 9781107024977

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The Business of Healthcare Innovation by Lawton R. Burns Pdf

Second edition of a wide-ranging analysis of business trends in the manufacturing segment of the healthcare industry.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
Publisher : National Academies Press
Page : 481 pages
File Size : 52,5 Mb
Release : 2006-01-20
Category : Medical
ISBN : 9780309096317

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Safe Medical Devices for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices Pdf

Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher : Unknown
Page : 1728 pages
File Size : 43,9 Mb
Release : 2016
Category : Rural development
ISBN : IND:30000155379914

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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2017: USDA Food Safety and Inspection Service; USDA Food and Nutrition Service; USDA Rural Development; USDA Research, Education, and Economics by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Pdf

Author : United States. Congress. Senate. Special Committee on Aging
Publisher : Unknown
Page : 208 pages
File Size : 46,7 Mb
Release : 2011
Category : Business & Economics
ISBN : UCSD:31822038349908

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A Delicate Balance by United States. Congress. Senate. Special Committee on Aging Pdf

Author : United States. General Accounting Office
Publisher : Unknown
Page : 40 pages
File Size : 46,6 Mb
Release : 1998
Category : Medical instruments and apparatus
ISBN : UIUC:30112004816838

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Medical Devices by United States. General Accounting Office Pdf