| Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal. | |
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MedLine Citation:
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PMID: 10182694 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 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 Aug |
Date Detail:
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Created Date: 1998-10-13 Completed Date: 1998-10-13 Revised Date: 2000-12-18 |
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: 45716-7 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* 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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