Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics Workshop Report

Name: Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics
Author: Institute Of Medicine

Auteur: Institute Of Medicine

Taal: Engels

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Auteur: Institute Of Medicine Board on Population Health and Public Health Practice

Co-auteur: Onbekend Institute Of Medicine

Engels
Paperback
9780309162067
10 juni 2011
132 pagina's

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Samenvatting

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. Table of Contents Front Matter 1 Introduction 2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices 3 Non-Food and Drug Administration Sources of Adverse Event Data 4 Postmarket Surveillance of Medical Devices: Panel Discussion 5 Other Select Topics Appendix A: Workshop Agenda Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data Appendix D: Trustworthy Medical Device Software

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Inhoud

Taal: en
Bindwijze: Paperback
Oorspronkelijke releasedatum: 10 juni 2011
Aantal pagina's: 132
Illustraties: Nee

Betrokkenen

Hoofdauteur: Institute Of Medicine
Tweede Auteur: Board on Population Health and Public Health Practice
Co Auteur: Institute Of Medicine
Hoofdredacteur: Theresa Wizemann
Hoofduitgeverij: National Academies Press

Overige kenmerken

Editie: 1
Studieboek: Nee
Verpakking breedte: 152 mm
Verpakking hoogte: 229 mm
Verpakking lengte: 229 mm
Verpakkingsgewicht: 293 g

EAN

EAN: 9780309162067

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Categorieën: Geneeskunde & Verpleging

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Taal: Engels
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Studieboek of algemeen: Studieboeken
Beschikbaarheid: Leverbaar

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