| Neurological devices; classification of human dura mater. Final rule. | |
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MedLine Citation:
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PMID: 14682309 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 68 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2003 Dec |
Date Detail:
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Created Date: 2003-12-18 Completed Date: 2004-01-05 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: 70435-6 Citation Subset: T |
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 Dura Mater* Equipment Safety Humans Legislation, Medical Tissue Transplantation / classification*, 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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