Document Detail

Medical devices; neurological devices; classification of cranial orthosis--FDA. Final rule.
MedLine Citation:
PMID:  10181519     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is classifying the cranial orthosis into class II (special controls). The special controls that will apply to the cranial orthosis are restriction to prescription use, biocompatibility testing, and certain labeling requirements. The agency is taking this action in response to a petition submitted under the Federal, Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying cranial orthosis into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Jul 
Date Detail:
Created Date:  1998-09-03     Completed Date:  1998-09-03     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  40650-2     Citation Subset:  H    
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MeSH Terms
Device Approval / legislation & jurisprudence*
Orthotic Devices / classification*,  standards
Product Labeling / legislation & jurisprudence
Skull / abnormalities*
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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