| Postmarket surveillance. Final rule. | |
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MedLine Citation:
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PMID: 12053947 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 67 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2002 Jun |
Date Detail:
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Created Date: 2002-06-07 Completed Date: 2002-06-14 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: 38878-92 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Consumer Product Safety
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legislation & jurisprudence* Costs and Cost Analysis Device Approval / legislation & jurisprudence* Equipment Design Equipment Safety Forms and Records Control Humans Product Surveillance, Postmarketing* / economics, standards 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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