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[null,null,"Titolo",null,"Medical devices and the public's health [[electronic resource] ] : the FDA 510(k) clearance process at 35 years / / Institute of Medicine of the National Academies"]
[null,null,"Pubbl/distr/stampa",null,"Washington, D.C., : National Academies Press, 2011"]
[null,null,"ISBN",null,"1-283-37627-X"]
[{"$nulls":4},"9786613376275"]
[{"$nulls":4},"0-309-21243-X"]
[null,null,"Descrizione fisica",null,"1 online resource (280 p.)"]
[null,null,"Disciplina",null,"363.19"]
[null,null,"Soggetti",null,"Medical instruments and apparatus - Safety regulations - United States"]
[{"$nulls":4},"Medical instruments and apparatus - Standards - United States"]
[{"$nulls":4},"Medical instruments and apparatus - Law and legislation - United States"]
[{"$nulls":4},"Public health - United States"]
[{"$nulls":4},"Electronic books."]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","\"Committee on the Public Health Effectiveness of the FDA 501(k) Clearance Process, Board on Population Health and Public Health Practice.\""]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"\"\"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\"\""]
[{"$nulls":4},"\"\"Appendix B: Committee Biographies\"\"\"\"Index\"\""]