Document Detail


Medical devices; immunology and microbiology devices; classification of norovirus serological reagents. Final rule.
MedLine Citation:
PMID:  22420063     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls.
Authors:
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  77     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-03-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  14272-4     Citation Subset:  T    
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