Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : 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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التفاصيل البيبلوغرافية
مؤلف مشترك: Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
مؤلفون آخرون: Wizemann, Theresa M.
التنسيق: Licensed eBooks
اللغة:الإنجليزية
منشور في: Washington, D.C. : National Academies Press, ©2011.
الوصول للمادة أونلاين:https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=372504
جدول المحتويات:
  • 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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