| Medical devices; humanitarian use of devices--FDA. Direct final rule; withdrawal. | |
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MedLine Citation:
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PMID: 10181716 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 63 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 1998 Jul |
Date Detail:
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Created Date: 1998-09-09 Completed Date: 1998-09-09 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 40825 Citation Subset: H |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval
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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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