Document Detail

Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Direct final rule; withdrawal.
MedLine Citation:
PMID:  10182563     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
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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:  1998-10-06     Completed Date:  1998-10-06     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  42699     Citation Subset:  H    
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MeSH Terms
Device Approval / legislation & jurisprudence*
Drug Approval / legislation & jurisprudence*
Equipment Safety
Equipment and Supplies
Forms and Records Control / legislation & jurisprudence
Industry / legislation & jurisprudence*
Time Factors
United States
United States Food and Drug Administration

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