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Public health effectiveness of the FDA 510(k) clearance process : balancing patient safety and innovation : workshop report / Theresa Wizemann, editor ; Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.
- Format:
- Book
- Author/Creator:
- Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process.
- Language:
- English
- Subjects (All):
- Public health--Standards--United States--Congresses.
- Public health.
- Public health--United States--Congresses.
- United States. Food and Drug Administration.
- United States.
- Physical Description:
- 1 online resource (141 p.)
- Edition:
- 1st ed.
- Other Title:
- FDA 510(k) clearance process
- Place of Publication:
- Washington, D.C. : National Academies Press, 2010.
- Language Note:
- English
- Summary:
- "The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop."-- Source other than Library of Congress.
- Contents:
- ""Front Matter""; ""Reviewers""; ""Contents""; ""Abbreviations""; ""1 Introduction""; ""2 Legislative History of the Medical Device Amendments of 1976""; ""3 Premarket Notification""; ""4 The Medical Device Industry Innovation Ecosystem""; ""5 The Global Framework for Regulation of Medical Devices""; ""6 Public Comments""; ""Appendix A: Workshop Agenda""; ""Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers""; ""Appendix C: Premarket Notification: A Key Element of US Medical Device Regulation
- Larry Kessler and Philip J. Phillips""
- ""Appendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation
- David W. Feigal, Jr.""
- Notes:
- Description based upon print version of record.
- Includes bibliographical references.
- ISBN:
- 9786612885709
- 9780309162906
- 0309162904
- 9781282885707
- 1282885707
- 9780309158503
- 0309158508
- OCLC:
- 690162710
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