Document Detail


Medical devices; exemption from premarket notification requirements; class I devices; technical amendment. Final rule; technical amendment.
MedLine Citation:
PMID:  11725800     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is amending the language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed.
Authors:
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  66     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2001 Jul 
Date Detail:
Created Date:  2001-11-28     Completed Date:  2001-12-07     Revised Date:  2009-11-03    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  38786-819     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Equipment and Supplies / classification*
Humans
Legislation, Medical
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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