MARC 主機 00000nam a22004333i 4500 
001    EBC3378915 
003    MiAaPQ 
005    20200713055402.0 
006    m     o  d |       
007    cr cnu|||||||| 
008    200713s2011    xx      o     ||||0 eng d 
020    9780309212434|q(electronic bk.) 
020    |z9780309212427 
035    (MiAaPQ)EBC3378915 
035    (Au-PeEL)EBL3378915 
035    (CaPaEBR)ebr10520725 
035    (CaONFJC)MIL337627 
035    (OCoLC)923284849 
040    MiAaPQ|beng|erda|epn|cMiAaPQ|dMiAaPQ 
050  4 KF3827.M4 -- N38 2011eb 
082 0  363.19 
100 1  Process, Committee on the Public Health Effectiveness of 
       the FDA 510(k) Clearance 
245 10 Medical Devices and the Public's Health :|bThe FDA 510(k) 
       Clearance Process at 35 Years 
264  1 Washington, D.C. :|bNational Academies Press,|c2011 
264  4 |c©2011 
300    1 online resource (280 pages) 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
505 0  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 
588    Description based on publisher supplied metadata and other
       sources 
590    Electronic reproduction. Ann Arbor, Michigan : ProQuest 
       Ebook Central, 2020. Available via World Wide Web. Access 
       may be limited to ProQuest Ebook Central affiliated 
       libraries 
650  0 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 
655  4 Electronic books 
700 1  Medicine, Institute of 
700 1  Practice, Board on Population Health and Public Health 
776 08 |iPrint version:|aProcess, Committee on the Public Health 
       Effectiveness of the FDA 510(k) Clearance|tMedical Devices
       and the Public's Health : The FDA 510(k) Clearance Process
       at 35 Years|dWashington, D.C. : National Academies Press,
       c2011|z9780309212427 
856 40 |uhttps://ebookcentral.proquest.com/lib/sinciatw/
       detail.action?docID=3378915|zClick to View