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Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule.
MedLine Citation:
PMID:  21516875     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' which will serve as the special control for this device.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  76     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-04-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  22805-7     Citation Subset:  T    
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