Document Detail


Medical devices; ear, nose, and throat devices; classification of the transcutaneous air conduction hearing aid system. Final rule.
MedLine Citation:
PMID:  12422884     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is classifying the transcutaneous air conduction hearing aid system (TACHAS) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. 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 amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  67     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2002 Nov 
Date Detail:
Created Date:  2002-11-07     Completed Date:  2002-11-15     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  67789-90     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Equipment Design
Equipment Safety
Hearing Aids / classification*
Humans
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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