FDA Warns Canadian Company for Marketing Device for Unapproved Uses
The Food and Drug Administration ordered a Canadian device manufacturer to stop marketing its device in the U.S. for unapproved uses, and renew its lapsed registration, in a warning letter dated March 13. According to FDA, Body, Mind & Soul,…
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Inc. is marketing its “Celluderm,” a therapeutic massager, for uses as diverse as boosting the immune system, reduction of water retention, relief of headaches and restless legs, and breast cyst reduction. Marketing for new intended uses requires premarket notification to the agency. Without a premarket approval notification (PMA), its device is adulterated. The company did not complete a facility registration for 2013 either, FDA said.