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
Call Number:Libro Electrónico
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:Inglés
Published: Washington, D.C. : National Academies Press, ©2011.
Subjects:
United States. > Food and Drug Administration > Congresses.
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.
Device Approval > standards
Device Approval > legislation & jurisprudence
Equipment Safety > standards
Santé publique > États-Unis > Congrès.
HEALTH & FITNESS > Safety.
Public health.
United States
United States.
Congress
Electronic resource.
Conference papers and proceedings.
Actes de congrès.
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