Document Detail

Patient access to medical devices.
MedLine Citation:
PMID:  23150977     Owner:  NLM     Status:  In-Data-Review    
To the Editor: In their Perspective article, Basu and Hassenplug (Aug. 9 issue)(1) claim that the time required for patients to gain access to high-risk medical devices is roughly similar in the United States and the European Union. However, the authors do not consider in their estimates the development time required before approval. Conformité Européenne (CE) marking requires only that a device be shown to be safe and that it performs as the manufacturer had intended, not that is has clinically significant efficacy. In contrast, the U.S. premarket-approval pathway requires substantial interaction with the Food and Drug Administration (FDA) to . . .
Stacy R Smith
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1963-5     Citation Subset:  AIM; IM    
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