LEADER 04750nam 2200721 a 450 001 9910958568903321 005 20200520144314.0 010 $a9786613376275 010 $a9780309212458 010 $a0309212456 010 $a9781283376273 010 $a128337627X 010 $a9780309212434 010 $a030921243X 035 $a(CKB)2550000000075209 035 $a(EBL)3378915 035 $a(SSID)ssj0000560582 035 $a(PQKBManifestationID)11338106 035 $a(PQKBTitleCode)TC0000560582 035 $a(PQKBWorkID)10570156 035 $a(PQKB)11242474 035 $a(MiAaPQ)EBC3378915 035 $a(Au-PeEL)EBL3378915 035 $a(CaPaEBR)ebr10520725 035 $a(CaONFJC)MIL337627 035 $a(OCoLC)923284849 035 $a(Perlego)4739100 035 $a(EXLCZ)992550000000075209 100 $a20120113d2011 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aMedical devices and the public's health $ethe FDA 510(k) clearance process at 35 years /$fInstitute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$d2011 215 $a1 online resource (280 p.) 300 $a"Committee on the Public Health Effectiveness of the FDA 501(k) Clearance Process, Board on Population Health and Public Health Practice." 311 08$a9780309212427 311 08$a0309212421 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"" 330 $a"Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical devices and the public's health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical devices and the public's health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework"--Publisher's description. 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 615 0$aMedical instruments and apparatus$xSafety regulations 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.).$bBoard on Population Health and Public Health Practice. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910958568903321 996 $aMedical devices and the public's health$94357097 997 $aUNINA