作者 Wizemann, Theresa
書名 Public Health Effectiveness of the FDA 510(k) Clearance Process : Balancing Patient Safety and Innovation: Workshop Report
出版項 Washington, D.C. : National Academies Press, 2010
©2010
國際標準書號 9780309158503 (electronic bk.)
9780309158497
book jacket
說明 1 online resource (141 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
附註 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
Description based on publisher supplied metadata and other sources
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2020. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries
鏈接 Print version: Wizemann, Theresa Public Health Effectiveness of the FDA 510(k) Clearance Process : Balancing Patient Safety and Innovation: Workshop Report Washington, D.C. : National Academies Press,c2010 9780309158497
主題 United States. -- Food and Drug Administration.;Public health -- Standards -- United States -- Congresses.;Public health -- United States -- Congresses
Electronic books
Alt Author Medicine, Institute of
Practice, Board on Population Health and Public Health
Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance