Document Detail


Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule.
MedLine Citation:
PMID:  10185812     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). Elsewhere in this issue 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.
Authors:
-
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Sep 
Date Detail:
Created Date:  1998-12-15     Completed Date:  1998-12-15     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  51825-7     Citation Subset:  H    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Industry / legislation & jurisprudence*
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  General administrative rulings and decisions; amendment to the examination and investigation sample ...
Next Document:  Medical devices; establishment registration and device listing for manufacturers and distributors of...