Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : 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.

Public health effectiveness of the FDA 510(k) clearance process : measuring postmarket performance and other select topics : workshop report /

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"The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical dev...

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Bibliographic Details
Corporate Author: Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Other Authors: Wizemann, Theresa M.
Format: Electronic eBook
Language:English
Published: Washington, D.C. : National Academies Press, ©2011.
Subjects:
United States. > Food and Drug Administration > Congresses.
United States > Food and Drug Administration
Public health > Equipment and supplies > Standards > United States > Congresses.
Public health > United States > Congresses.
Device Approval > standards
Device Approval > legislation & jurisprudence
Equipment Safety > standards
United States
Congress
proceedings (reports)
Conference papers and proceedings.
Online Access: Full text (Wentworth users only)
Local Note:ProQuest Ebook Central

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