Document Detail


Medical Devices; general and plastic surgery devices; classification of contact cooling system for aesthetic use. Final rule.
MedLine Citation:
PMID:  21351681     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.
Authors:
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  76     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-02-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  6551-3     Citation Subset:  T    
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