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

Bibliographic Details
Corporate Authors: 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
Other Authors: Wizemann, Theresa M. (Editor)
Format: eBook
Language:English
Published: Washington, D.C. National Academies Press [2010], ©2010, 2010
Subjects:
Equipment Safety / Standards
United States
Device Approval / Legislation & Jurisprudence
Device Approval / Standards
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Table of Contents:
  • Introduction
  • Legislative history of the Medical Device Amendments of 1976
  • Premarket notification
  • The medical device industry innovation ecosystem
  • The global framework for regulation of medical devices
  • Public comments
  • Includes bibliographical references

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