Medical Devices and the Public's Health : The FDA 510(k) Clearance Process at 35 Years.
Title:
Medical Devices and the Public's Health : The FDA 510(k) Clearance Process at 35 Years.
Author:
Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance.
ISBN:
9780309212434
Physical Description:
1 online resource (280 pages)
Contents:
FrontMatter -- Reviewers -- Acknowledgments -- Preface -- Contents -- Boxes, Figures, and Tables -- Acronyms and Abbreviations -- Summary -- 1 Introduction -- 2 Key Medical-Device Legislative and Regulatory Actions -- 3 Components of US Medical-Device Regulation -- 4 The 510(k) Clearance Process -- 5 Postmarketing Surveillance, Compliance, and Enforcement -- 6 External Factors That Affect the Medical-Device Regulatory System -- 7 Conclusions and Recommendations -- Appendix A: History of Medical-Device Legislation and Regulation in the United States -- Appendix B: Committee Biographies -- Index.
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.
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