| Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule. | |
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MedLine Citation:
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PMID: 10179334 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors, and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives a significant adverse comment and withdraws this direct final rule. |
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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 May |
Date Detail:
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Created Date: 1998-06-25 Completed Date: 1998-06-25 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: 26069-77 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* Equipment Failure Equipment Safety* Humans Iatrogenic Disease Information Services / legislation & jurisprudence Product Surveillance, Postmarketing* 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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