| Medical devices; reports of corrections and removals; companion to direct final rule--FDA. Proposed rule. | |
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MedLine Citation:
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PMID: 10181727 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is proposing to amend its regulations governing reports of corrections and removal of medical devices to eliminate the requirement for distributors to make such reports. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is issued under FDAMA and the act as amended. |
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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: 1998-09-09 Completed Date: 1998-09-09 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: 42300-4 Citation Subset: H |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval
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legislation & jurisprudence* Forms and Records Control / legislation & jurisprudence Industry / legislation & jurisprudence Product Surveillance, Postmarketing* Risk Safety 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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