Document Detail

Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule.
MedLine Citation:
PMID:  10179319     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval application (PMA) supplements to allow 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). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this tissue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.
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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 Apr 
Date Detail:
Created Date:  1998-06-25     Completed Date:  1998-06-25     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  20530-3     Citation Subset:  H    
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MeSH Terms
Device Approval / legislation & jurisprudence*
Equipment Safety
Forms and Records Control / legislation & jurisprudence
Industry / legislation & jurisprudence*
Time Factors
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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