Document Detail


Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule.
MedLine Citation:
PMID:  11706859     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  66     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2001 Mar 
Date Detail:
Created Date:  2001-11-13     Completed Date:  2001-12-07     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  15796-8     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Drug Compounding / classification*,  instrumentation
Equipment Design
Equipment Safety
Humans
Legislation, Drug
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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