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

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Description	1 online resource (xii, 128 pages) : illustrations (some color)
Physical Medium	polychrome
Description	text file
Bibliography	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.
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.
Local Note	eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Subject	United States. Food and Drug Administration.
	United States. Food and Drug Administration.
	United States. Food and Drug Administration.
	Public health -- Equipment and supplies -- Standards -- United States -- Congresses.
	Public health.
	Equipment and supplies.
	United States.
	Public health -- United States -- Congresses.
	Device Approval -- legislation & jurisprudence.
	Equipment Safety -- standards.
	Consumer Product Safety -- legislation & jurisprudence.
	Equipment and Supplies -- standards.
	Public Policy.
	Public Health.
	United States.
Genre/Form	Congress.
	Electronic books.
	Conference papers and proceedings.
	Conference papers and proceedings.
Added 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.
Added Title	FDA 510(k) clearance process
Other Form:	Print version: Public health effectiveness of the FDA 510(k) clearance process. Washington, D.C. : National Academies Press, [2010], ©2010 9780309158497 (OCoLC)680812545
ISBN	9780309158503 (electronic book)
	0309158508 (electronic book)
	1282885707
	9781282885707
	0309162068
	9780309162067
	9780309158497
	0309158494

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