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Medical devices and the public's health : the FDA 510(k) clearance process at 35 years / 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
Resource type: Ressourcentyp: Buch (Online)Book (Online)Language: English Publisher: Washington, D.C : National Academies Press, c2011Copyright date: ©2011Edition: Online-AusgDescription: Online-Ressource (1 online resource (xx, 298 p.)) : illISBN:- 9781283376273
- 128337627X
- 9780309212434
- 9780309212427
- United States Food and Drug Administration
- Medical instruments and apparatus
- Product safety
- United States. -- Food and Drug Administration
- 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
- Equipment Safety -- United States
- Equipment and Supplies -- United States
- Device Approval -- United States
- Electronic books
- Electronic books
- 610.284
- 610.28/4 23
- 363.19
- R856.6
- KF3827.M4.N38 2011eb
- WB 26
Contents:
Summary: FrontMatter -- 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.PPN: PPN: 80949289XPackage identifier: Produktsigel: ZDB-26-MYL | ZDB-30-PAD | ZDB-30-PQE
""FrontMatter""; ""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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Also available online in Open Book format via the National Academies Press home page.
Reproduktion. Also available online in Open Book format via the National Academies Press home page