Document Detail

A US FDA medical device update, Part II.
MedLine Citation:
PMID:  10163518     Owner:  NLM     Status:  MEDLINE    
This column in last month's edition discussed answers to some of the questions raised at a recent Food and Drug Administration (FDA) conference held in Paris. This article continues that discussion and includes questions and answers concerning harmonization and good manufacturing practice (GMP) requirements. As in the preceding column, the answers were provided by FDA speakers at the conference or subsequently confirmed in discussions with the author.
M E Donawa
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Medical device technology     Volume:  7     ISSN:  1048-6690     ISO Abbreviation:  Med Device Technol     Publication Date:  1996 Sep 
Date Detail:
Created Date:  1996-12-05     Completed Date:  1996-12-05     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9215490     Medline TA:  Med Device Technol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  12-6, 18     Citation Subset:  T    
Donawa and Associates Ltd., Rome, Italy.
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MeSH Terms
Device Approval / standards*
Equipment and Supplies / standards*,  supply & distribution
Guidelines as Topic*
United States
United States Food and Drug Administration*

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