| 說明 |
1 online resource (280 pages) |
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text txt rdacontent |
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computer c rdamedia |
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online resource cr rdacarrier |
| 附註 |
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 |
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Description based on publisher supplied metadata and other sources |
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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: Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Medical Devices and the Public's Health : The FDA 510(k) Clearance Process at 35 Years
Washington, D.C. : National Academies Press,c2011 9780309212427
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| 主題 |
United States. -- Food and Drug Administration.;Medical instruments and apparatus -- Safety regulations -- United States.;Medical instruments and apparatus -- Standards -- United States.;Medical instruments and apparatus -- Law and legislation -- United States.;Public health -- United States
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Electronic books
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| Alt Author |
Medicine, Institute of
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Practice, Board on Population Health and Public Health
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