作者 Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance
書名 Medical Devices and the Public's Health : The FDA 510(k) Clearance Process at 35 Years
出版項 Washington, D.C. : National Academies Press, 2011
©2011
國際標準書號 9780309212434 (electronic bk.)
9780309212427
book jacket
說明 1 online resource (280 pages)
text txt rdacontent
computer c rdamedia
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
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: 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
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
Electronic books
Alt Author Medicine, Institute of
Practice, Board on Population Health and Public Health