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).
Related Documents :
12617085 - Medical devices; hematology and pathology devices; reclassification of automated blood ...
11317995 - Treating aerophagia with contingent physical guidance.
20948825 - Recent advances in closure of atrial septal defects and patent foramen ovale.
10557545 - The fda may not regulate tobacco products as "drugs" or as "medical devices".
19453735 - Contrasting thoughts about deceptive orchids: a response to sobel and randle.
2604005 - Endogenous cholecystokinin does not decrease food intake or gastric emptying in fasted ...
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    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
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

Previous Document:  Medicare program; hospice wage index--HCFA. Notice.
Next Document:  List of drug products that have been withdrawn or removed from the market for reasons of safety or e...