Document Detail


Neurological devices; classification of human dura mater. Final rule.
MedLine Citation:
PMID:  14682309     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  68     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2003 Dec 
Date Detail:
Created Date:  2003-12-18     Completed Date:  2004-01-05     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  70435-6     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / 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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