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

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

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Description 1 online resource (xii, 128 pages) : illustrations (some color) Series Online access: NCBI NCBI Bookshelf 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 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 Bibliography Includes bibliographical references Notes English Print version record Subject United States. Food and Drug Administration. SUBJECT United States. Food and Drug Administration fast Subject Public health -- Equipment and supplies -- Standards -- United States -- Congresses Public health -- United States -- Congresses Device Approval -- standards Device Approval -- legislation & jurisprudence Equipment Safety -- standards MEDICAL -- Family & General Practice. MEDICAL -- Osteopathy. MEDICAL. MEDICAL -- Holistic Medicine. HEALTH & FITNESS -- Reference. MEDICAL -- Essays. MEDICAL -- Alternative Medicine. HEALTH & FITNESS -- Holism. Public health SUBJECT United States https://id.nlm.nih.gov/mesh/D014481 Subject United States Genre/Form proceedings (reports) Conference papers and proceedings Conference papers and proceedings. Actes de congrès. Form Electronic book Author Wizemann, Theresa M 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, author. ISBN 9780309158503 0309158508 1282885707 9781282885707 0309162068 9780309162067 9786612885709 661288570X 0309162904 9780309162906

Other Titles FDA 510(k) clearance process

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