Document Detail

Medical devices; classification/reclassification of immunohistochemistry reagents and kits--FDA. Final rule.
MedLine Citation:
PMID:  10179865     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is issuing a final rule to classify/reclassify immunohistochemistry reagents and kits (IHC's) into three classes depending on intended use. FDA is classifying/reclassifying into class I (general controls) and exempt from premarket notification requirements IHC's used as adjunctive tests and presenting a low risk to public health. FDA is classifying/reclassifying into class II (special control) IHC's that detect or measure certain target analytes and that provide prognostic or predictive data that is not confirmed by routine histopathologic control specimens. The results of the class II IHC's are reported independently to the clinician, and the performance claims are widely accepted and supported by valid scientific evidence. FDA is classifying/reclassifying into class III (premarket approval) IHC's intended for any other use. The scope of products covered by this final rule includes both pre-1976 devices that have not been previously classified, as well as post-1976 devices that are statutorily classified into class III. The intent of this final rule is to regulate pre-1976 devices and post-1976 devices in a consistent fashion. Therefore, FDA is classifying or reclassifying these products as applicable.
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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 Jun 
Date Detail:
Created Date:  1998-07-02     Completed Date:  1998-07-02     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  30132-42     Citation Subset:  H    
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MeSH Terms
Device Approval / legislation & jurisprudence*
Equipment Safety
Reagent Kits, Diagnostic / classification*
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Reagent Kits, Diagnostic

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

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