Document Detail


Medical devices; humanitarian use of devices--FDA. Direct final rule.
MedLine Citation:
PMID:  10178430     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is amending the regulations governing humanitarian use devices. These 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). 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:
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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:  1998-05-26     Completed Date:  1998-05-26     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  19185-90     Citation Subset:  H    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Emergency Treatment / standards
Equipment Safety
Humans
Research Design / standards*
Risk-Taking
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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