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200 14$aThe last testimony, & declaration of the Reverend Samuel Crossman, D.D. and Dean of Bristoll$b[electronic resource] $esetting forth his dutiful, and true affection to the Church of England as by law established
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200 10$aMedical devices and the public's health$b[electronic resource] $ethe FDA 510(k) clearance process at 35 years /$fInstitute of Medicine of the National Academies
210   $aWashington, D.C. $cNational Academies Press$d2011
215   $a1 online resource (280 p.)
300   $a"Committee on the Public Health Effectiveness of the FDA 501(k) Clearance Process, Board on Population Health and Public Health Practice."
311   $a0-309-21242-1 
320   $aIncludes bibliographical references and index.
327   $a""Front Matter""; ""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""
327   $a""Appendix B: Committee Biographies""""Index""
606   $aMedical instruments and apparatus$xSafety regulations$zUnited States
606   $aMedical instruments and apparatus$xStandards$zUnited States
606   $aMedical instruments and apparatus$xLaw and legislation$zUnited States
606   $aPublic health$zUnited States
608   $aElectronic books.
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615  0$aMedical instruments and apparatus$xStandards
615  0$aMedical instruments and apparatus$xLaw and legislation
615  0$aPublic health
676   $a363.19
712 02$aNational Research Council (U.S.).$bCommittee on the Public Health Effectiveness of the FDA 501(k) Clearance Process.
712 02$aInstitute of Medicine (U.S.).$bBoard on Population Health and Public Health Practice.
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