| Patient access to medical devices. | |
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MedLine Citation:
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PMID: 23150977 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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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 . . . |
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Authors:
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Stacy R Smith |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: The New England journal of medicine Volume: 367 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2012 Nov |
Date Detail:
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Created Date: 2012-11-15 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1963-5 Citation Subset: AIM; IM |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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