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Record Nr. |
UNINA9910457208603321 |
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Titolo |
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 |
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Pubbl/distr/stampa |
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Washington, D.C., : National Academies Press, 2011 |
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ISBN |
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1-283-37627-X |
9786613376275 |
0-309-21243-X |
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Descrizione fisica |
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1 online resource (280 p.) |
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Disciplina |
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Soggetti |
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Medical instruments and apparatus - Safety regulations - United States |
Medical instruments and apparatus - Standards - United States |
Medical instruments and apparatus - Law and legislation - United States |
Public health - United States |
Electronic books. |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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"Committee on the Public Health Effectiveness of the FDA 501(k) Clearance Process, Board on Population Health and Public Health Practice." |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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""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"" |
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