Document Detail

Medical devices; reclassification of tumor-associated antigen immunological test system--FDA. Final rule.
MedLine Citation:
PMID:  10179301     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is announcing that it is codifying the reclassification of tumor-associated antigen immunological test systems intended as an aid in monitoring patients for disease progression or response to therapy or for the detection of recurrent or residual disease from class III (premarket approval) to class II (special controls). FDA is also announcing that it has issued an order in the form of a letter to Centocar, Inc., reclassifying serum tumor markers into class II. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  62     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1997 Dec 
Date Detail:
Created Date:  1998-06-25     Completed Date:  1998-06-25     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  66003-5     Citation Subset:  H    
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MeSH Terms
Antigens, Neoplasm / classification*
Disease Progression
Drug Approval / legislation & jurisprudence*
Neoplasms / therapy*
Tumor Markers, Biological / classification*,  standards
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Antigens, Neoplasm; 0/Tumor Markers, Biological

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

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