Document Detail


Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal.
MedLine Citation:
PMID:  10182694     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Aug 
Date Detail:
Created Date:  1998-10-13     Completed Date:  1998-10-13     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  45716-7     Citation Subset:  H    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
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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