Document Detail


Medical devices; reports of corrections and removals; companion to direct final rule--FDA. Proposed rule.
MedLine Citation:
PMID:  10181727     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is proposing to amend its regulations governing reports of corrections and removal of medical devices to eliminate the requirement for distributors to make such reports. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is issued under FDAMA and the act as amended.
Authors:
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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:  1998-09-09     Completed Date:  1998-09-09     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  42300-4     Citation Subset:  H    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Forms and Records Control / legislation & jurisprudence
Industry / legislation & jurisprudence
Product Surveillance, Postmarketing*
Risk
Safety
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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