Research Catalog

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

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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Details

Additional Authors
  • Wizemann, Theresa M.
  • Institute of Medicine (U.S.). Board on Population Health and Public Health Practice, sponsoring body.
  • Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, sponsoring body.
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
  • United States. Food and Drug Administration
  • United States. Food and Drug Administration
  • Public health > Equipment and supplies > Standards > United States > Congresses
  • Public health > United States > Congresses
  • Public health
  • Device Approval > standards
  • Device Approval > legislation & jurisprudence
  • Equipment Safety > standards
  • United States
Genre/Form
  • Conference papers and proceedings.
  • Actes de congrès.
  • 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
LCCN
  • 2012405517
  • 10.17226/12960
OCLC
  • ocn680812545
  • 680812545
  • SCSB-9238434
Owning Institutions
Princeton University Library