Public Health Effectiveness of the FDA 510(k) Clearance Process

Balancing Patient Safety and Innovation: Workshop Report

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

Buch | Softcover

140 Seiten

2010
National Academies Press (Verlag)
978-0-309-15849-7 (ISBN)

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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Table of Contents

Front Matter
1 Introduction
2 Legislative History of the Medical Device Amendments of 1976
3 Premarket Notification
4 The Medical Device Industry Innovation Ecosystem
5 The Global Framework for Regulation of Medical Devices
6 Public Comments
Appendix A: Workshop Agenda
Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers
Appendix C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. Phillips
Appendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation--David W. Feigal, Jr.

1 Front Matter; 2 1 Introduction; 3 2 Legislative History of the Medical Device Amendments of 1976; 4 3 Premarket Notification; 5 4 The Medical Device Industry Innovation Ecosystem; 6 5 The Global Framework for Regulation of Medical Devices; 7 6 Public Comments; 8 Appendix A: Workshop Agenda; 9 Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers; 10 Appendix C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. Phillips; 11 Appendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation--David W. Feigal, Jr

Erscheint lt. Verlag	4.11.2010
Verlagsort	Washington
Sprache	englisch
Maße	152 x 229 mm
Themenwelt	Studium ► Querschnittsbereiche ► Prävention / Gesundheitsförderung
ISBN-10	0-309-15849-4 / 0309158494
ISBN-13	978-0-309-15849-7 / 9780309158497
Zustand	Neuware