Public Health Effectiveness of the FDA 510(k) Clearance Process : Balancing Patient Safety and Innovation: Workshop Report.
Title:
Public Health Effectiveness of the FDA 510(k) Clearance Process : Balancing Patient Safety and Innovation: Workshop Report.
Author:
Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance.
ISBN:
9780309158503
Physical Description:
1 online resource (141 pages)
Contents:
FrontMatter -- Reviewers -- Contents -- Abbreviations -- 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.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Genre:
Electronic Access:
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