Public Health Effectiveness of the FDA 510(k) Clearance Process : Measuring Postmarket Performance and Other Select Topics-Workshop Report.
Title:
Public Health Effectiveness of the FDA 510(k) Clearance Process : Measuring Postmarket Performance and Other Select Topics-Workshop Report.
Author:
Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance.
ISBN:
9780309162074
Physical Description:
1 online resource (132 pages)
Contents:
FrontMatter -- Reviewers -- Contents -- Abbreviations -- 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.
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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