LEADER 04356nam 2200709Ia 450 001 9910959650703321 005 20251017110107.0 010 $a9786613134974 010 $a9780309215114 010 $a0309215110 010 $a9781283134972 010 $a1283134977 010 $a9780309162074 010 $a0309162076 035 $a(CKB)2550000000037268 035 $a(EBL)3378791 035 $a(SSID)ssj0000525142 035 $a(PQKBManifestationID)11340975 035 $a(PQKBTitleCode)TC0000525142 035 $a(PQKBWorkID)10488241 035 $a(PQKB)10767014 035 $a(MiAaPQ)EBC3378791 035 $a(Au-PeEL)EBL3378791 035 $a(CaPaEBR)ebr10478243 035 $a(CaONFJC)MIL313497 035 $a(OCoLC)923283535 035 $a(Perlego)4738265 035 $a(DNLM)1565900 035 $a(EXLCZ)992550000000037268 100 $a20101112d2011 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aPublic health effectiveness of the FDA 510(k) clearance process $ebalancing patient safety and innovation : workshop report /$fTheresa Wizemann, editor ; Committee on the Public Health Effectiveness of the FDA 510(k) clearance process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$dc2011 215 $a1 online resource (132 p.) 300 $aDescription based upon print version of record. 311 08$a9780309162067 311 08$a0309162068 320 $aIncludes bibliographical references. 327 $a""Front Matter""; ""Reviewers""; ""Contents""; ""Abbreviations""; ""1 Introduction""; ""2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices""; ""3 Non-Food and Drug Administration Sources of Adverse Event Data""; ""4 Postmarket Surveillance of Medical Devices: Panel Discussion""; ""5 Other Select Topics""; ""Appendix A: Workshop Agenda""; ""Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers""; ""Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data"" 327 $a""Appendix D: Trustworthy Medical Device Software"" 330 $a"The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants."--Publisher's description. 517 3 $aFDA 510(k) clearance process 606 $aPublic health$xEquipment and supplies$xStandards$zUnited States$vCongresses 606 $aPublic health$zUnited States$vCongresses 615 0$aPublic health$xEquipment and supplies$xStandards 615 0$aPublic health 676 $a362.1068 701 $aWizemann$b Theresa M$0890630 712 02$aInstitute of Medicine (U.S.).$bBoard on Population Health and Public Health Practice. 712 02$aInstitute of Medicine (U.S.).$bCommittee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910959650703321 996 $aPublic health effectiveness of the FDA 510(k) clearance process$94361556 997 $aUNINA