Public health effectiveness of the FDA 510(k) clearance process : balancing patient safety and innovation : workshop report

Public health effectiveness of the FDA 510(k) clearance process balancing patient safety and innovation : workshop report

"The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical dev...

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Detalles Bibliográficos
Autores Corporativos: Institute of Medicine (U.S.). Board on Population Health and Public Health Practice (-), Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Otros Autores: Wizemann, Theresa M. (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press c2011.
Edición:1st ed
Materias:
United States. > Food and Drug Administration.
Public health > Equipment and supplies > Standards > United States > Congresses.
Public health > United States > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820291806719
Tabla de Contenidos:
  • ""Front Matter""; ""Reviewers""; ""Contents""; ""Abbreviations""; ""1 Introduction""; ""2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices""; ""3 Non-Food and Drug Administration Sources of Adverse Event Data""; ""4 Postmarket Surveillance of Medical Devices: Panel Discussion""; ""5 Other Select Topics""; ""Appendix A: Workshop Agenda""; ""Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers""; ""Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data""
  • ""Appendix D: Trustworthy Medical Device Software""

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