Document Detail


Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule.
MedLine Citation:
PMID:  11010624     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. 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 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:  65     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2000 Apr 
Date Detail:
Created Date:  2000-09-22     Completed Date:  2000-09-22     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  18236-7     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Electric Stimulation Therapy / instrumentation*
Equipment Design
Equipment Safety
Equipment and Supplies / classification*
Gastroenterology / instrumentation
Humans
United States
United States Food and Drug Administration
Urinary Incontinence / therapy
Urology / instrumentation

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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