Document Detail


Postmarket surveillance. Final rule.
MedLine Citation:
PMID:  12053947     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  67     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2002 Jun 
Date Detail:
Created Date:  2002-06-07     Completed Date:  2002-06-14     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  38878-92     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Consumer Product Safety / legislation & jurisprudence*
Costs and Cost Analysis
Device Approval / legislation & jurisprudence*
Equipment Design
Equipment Safety
Forms and Records Control
Humans
Product Surveillance, Postmarketing* / economics,  standards
United States
United States Food and Drug Administration*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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