Public Health Effectiveness of the FDA 510(k) Clearance Process : Balancing Patient Safety and Innovation: Workshop Report Paperback / softback
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
Edited by Theresa Wizemann
Paperback / softback
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Description
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 ContentsFront Matter1 Introduction2 Legislative History of the Medical Device Amendments of 19763 Premarket Notification4 The Medical Device Industry Innovation Ecosystem5 The Global Framework for Regulation of Medical Devices6 Public CommentsAppendix A: Workshop AgendaAppendix B: Biographic Information on Invited Speakers, Panelists,and Authors of Commissioned PapersAppendix C: Premarket Notification: A Key Element of US MedicalDevice Regulation--Larry Kessler and Philip J.
PhillipsAppendix D: Impact of the Regulatory Framework on Medical DeviceDevelopment and Innovation--David W.
Feigal, Jr.
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Available to Order - This title is available to order, with delivery expected within 2 weeks
- Format:Paperback / softback
- Pages:140 pages
- Publisher:National Academies Press
- Publication Date:04/11/2010
- Category:
- ISBN:9780309158497
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Information
-
Available to Order - This title is available to order, with delivery expected within 2 weeks
- Format:Paperback / softback
- Pages:140 pages
- Publisher:National Academies Press
- Publication Date:04/11/2010
- Category:
- ISBN:9780309158497