Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : workshop report

Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report

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"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
Autor Corporativo: 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.
Colección:EBSCO Academic eBook Collection Complete.
Acceso en línea:Conectar con la versión electrónica
Ver en Universidad de Navarra:https://innopac.unav.es/record=b31189222*spi
Tabla de Contenidos:
  • Introduction
  • Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices
  • Non-Food and Drug Administration Sources of Adverse Event Data
  • Postmarket Surveillance of Medical Devices: Panel Discussion
  • 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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