00890nam0-2200313 --450 991028035320332120180724110750.0978-88-15-24460-4IT2013-155420180724d2013----kmuy0itay5050 baitaIT 001yy<<La >>formazione degli Stati UnitiArnaldo Testi2. ed.BolognaIl mulino2013265 p.ill.22 cm<<Le >>vie della civiltàA pagina IV di copertina: 2. ed. aggiornataStati Uniti d'AmericaStoria97322itaTesti,Arnaldo133803ITUNINAREICATUNIMARCBK9910280353203321XIV D 2461568/2018FSPBCFSPBCFormazione degli Stati Uniti748473UNINA04611nam 2200649 a 450 991078152130332120230725054356.00-309-21245-61-283-37627-X97866133762750-309-21243-X(CKB)2550000000075209(EBL)3378915(SSID)ssj0000560582(PQKBManifestationID)11338106(PQKBTitleCode)TC0000560582(PQKBWorkID)10570156(PQKB)11242474(MiAaPQ)EBC3378915(Au-PeEL)EBL3378915(CaPaEBR)ebr10520725(CaONFJC)MIL337627(OCoLC)923284849(EXLCZ)99255000000007520920120113d2011 uy 0engurcn|||||||||txtccrMedical devices and the public's health[electronic resource] the FDA 510(k) clearance process at 35 years /Institute of Medicine of the National AcademiesWashington, D.C. National Academies Press20111 online resource (280 p.)"Committee on the Public Health Effectiveness of the FDA 501(k) Clearance Process, Board on Population Health and Public Health Practice."0-309-21242-1 Includes bibliographical references and index.""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""""Appendix B: Committee Biographies""""Index"""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.Medical instruments and apparatusSafety regulationsUnited StatesMedical instruments and apparatusStandardsUnited StatesMedical instruments and apparatusLaw and legislationUnited StatesPublic healthUnited StatesMedical instruments and apparatusSafety regulationsMedical instruments and apparatusStandardsMedical instruments and apparatusLaw and legislationPublic health363.19National Research Council (U.S.).Committee on the Public Health Effectiveness of the FDA 501(k) Clearance Process.Institute of Medicine (U.S.).Board on Population Health and Public Health Practice.MiAaPQMiAaPQMiAaPQBOOK9910781521303321Medical devices and the public's health3825351UNINA