Document Detail

FDA modernization act of 1997: guidance on medical device tracking; availability--FDA. Notice.
MedLine Citation:
PMID:  10177505     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance on Medical Device Tracking." This guidance is intended to provide guidelines to manufacturers and distributors about their responsibilities for medical device tracking under the Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act (FDAMA). This guidance addresses what statutory and regulatory tracking requirements have changed and what requirements remain the same under the FDAMA amendments. The agency requests comments on this guidance. Elsewhere, in this issue of the Federal Register, FDA is announcing new orders to manufacturers of devices that were subject to tracking.
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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 Mar 
Date Detail:
Created Date:  1998-04-28     Completed Date:  1998-04-28     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  10640-1     Citation Subset:  H    
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MeSH Terms
Device Approval / standards*
Equipment and Supplies / standards
Guidelines as Topic*
Product Surveillance, Postmarketing / standards*
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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