New technology news: "Off-label" use of dermatological device to cut body fat
Credentialing Resource Center Connection, April 1, 2010
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Practitioners across the country are beginning to find an “off-label” use for a device which has been approved by the FDA for cooling skin during dermatological procedures. They are using the Zeltiq device to remove body fat through a freezing process, according to a March 29 Boston Globe article.
Although other countries have approved Zeltiq for fat reduction purposes, the FDA has not. Practitioners are allowed to use the device for “off-label” purposes, meaning a process other than ones it is being marketed for, but the manufacture is not allowed to market it for those purposes.
It is a best practice for medical staffs to know whether practitioners are using devices for their FDA-approved purposes or in an “off-label” way.
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