Document Detail

Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Final rule.
MedLine Citation:
PMID:  10185825     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval (PMA) supplements to provide for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
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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 Oct 
Date Detail:
Created Date:  1998-12-17     Completed Date:  1998-12-17     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  54042-4     Citation Subset:  H    
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MeSH Terms
Device Approval / legislation & jurisprudence*
Industry / legislation & jurisprudence
Time Management
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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