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

• Pubblicazione: Washington, D.C., : National Academies Press, 2011
• Descrizione fisica: 1 online resource (280 p.)
• Disciplina: 363.19
• Soggetto topico: 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
• Soggetto genere / forma: Electronic books.
• Note generali: "Committee on the Public Health Effectiveness of the FDA 501(k) Clearance Process, Board on Population Health and Public Health Practice."
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: ""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""
• Titolo autorizzato: Medical devices and the public's health
• ISBN: 1-283-37627-X; 9786613376275; 0-309-21243-X
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910457208603321
• Lo trovi qui: Univ. Federico II