Document Detail

Neurological devices; classification of human dura mater. Final rule.
MedLine Citation:
PMID:  14682309     Owner:  HSR     Status:  MEDLINE    
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.
Related Documents :
8720159 - Preparing for and handling the results of regulatory inspections of biomedical facilities.
10558579 - Clinical studies of safety and effectiveness of orphan products; availability of grants...
2653609 - Lapidus: when and why?
24924329 - Increased distractability in capons: an adult parallel to androgen-induced effects in t...
14594019 - Medical devices; immunology and microbiology devices; classification of the endotoxin a...
11706859 - Medical device; exemption from premarket notification; class ii devices; pharmacy compo...
1610759 - The effects of elemental diet following ileo-endorectal pull-through in rats.
24266419 - Development of an active food packaging system with antioxidant properties based on gre...
15083739 - Real-time nucleic acid-based detection methods for pathogenic bacteria in food.
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    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Device Approval / legislation & jurisprudence
Dura Mater*
Equipment Safety
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

Previous Document:  Rethinking diabetes prevention and control in racial and ethnic communities.
Next Document:  NMR studies of oxyleghemoglobin: assignment of distal histidine proton resonances and evidence for p...