Research Catalog

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.

Title
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.
Publication
Washington, D.C. : National Academies Press, [2010], ©2010.

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Additional Authors
  • Institute of Medicine (U.S.). Board on Population Health and Public Health Practice, author.
  • Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) clearance process, Board on Population Health and Public Health Practice, author.
  • Wizemann, Theresa M.,
Description
xii, 128 pages : illustrations (some color); 23 cm.
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."--resource home page.
Alternative Title
FDA 510(k) clearance process
Subject
  • Consumer Product Safety > legislation & jurisprudence
  • Device Approval > legislation & jurisprudence
  • Equipment Safety > standards
  • Equipment and Supplies > standards
  • Public Health
  • Public Policy
  • Public health > Standards > United States > Congresses
  • Public health > United States > Congresses
  • United States
  • United States. Food and Drug Administration
Genre/Form
Congress.
Bibliography (note)
  • Includes bibliographical references.
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.
ISBN
  • 9780309158497
  • 0309158494
Owning Institutions
Columbia University Libraries