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008    200713s2010    xx      o     ||||0 eng d 
020    9780309158503|q(electronic bk.) 
020    |z9780309158497 
035    (MiAaPQ)EBC3378673 
035    (Au-PeEL)EBL3378673 
035    (CaPaEBR)ebr10425162 
035    (CaONFJC)MIL288570 
035    (OCoLC)690162710 
040    MiAaPQ|beng|erda|epn|cMiAaPQ|dMiAaPQ 
050  4 RA399.A3 -- I57 2010eb 
082 0  610 
100 1  Wizemann, Theresa 
245 10 Public Health Effectiveness of the FDA 510(k) Clearance 
       Process :|bBalancing Patient Safety and Innovation: 
       Workshop Report 
264  1 Washington, D.C. :|bNational Academies Press,|c2010 
264  4 |c©2010 
300    1 online resource (141 pages) 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
505 0  FrontMatter -- Reviewers -- Contents -- Abbreviations -- 1
       Introduction -- 2 Legislative History of the Medical 
       Device Amendments of 1976 -- 3 Premarket Notification -- 4
       The Medical Device Industry Innovation Ecosystem -- 5 The 
       Global Framework for Regulation of Medical Devices -- 6 
       Public Comments -- Appendix A: Workshop Agenda -- Appendix
       B: Biographic Information on Invited Speakers, Panelists, 
       and Authors of Commissioned Papers -- Appendix C: 
       Premarket Notification: A Key Element of US Medical Device
       Regulation--Larry Kessler and Philip J. Phillips -- 
       Appendix D: Impact of the Regulatory Framework on Medical 
       Device Development and Innovation--David W. Feigal, Jr 
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.;Public 
       health -- Standards -- United States -- Congresses.;Public
       health -- United States -- Congresses 
655  4 Electronic books 
700 1  Medicine, Institute of 
700 1  Practice, Board on Population Health and Public Health 
700 1  Process, Committee on the Public Health Effectiveness of 
       the FDA 510(k) Clearance 
776 08 |iPrint version:|aWizemann, Theresa|tPublic Health 
       Effectiveness of the FDA 510(k) Clearance Process : 
       Balancing Patient Safety and Innovation: Workshop Report
       |dWashington, D.C. : National Academies Press,c2010
       |z9780309158497 
856 40 |uhttps://ebookcentral.proquest.com/lib/sinciatw/
       detail.action?docID=3378673|zClick to View