US Food and Drugs Administration issues warning to cosmetic device manufacturers

US Food and Drugs Administration issues warning to cosmetic device manufacturers

The US Food and Drugs Administration (FDA) has issued warning letters to several manufacturers and distributors of cosmetic devices to make them aware of the distinction between the legal definition of cosmetic and medical devices.

The FDA has identified several cosmetic devices marketed for regrowing hair, spider vein removal, dermabrasion and weight reduction which, although intended to alter a person’s appearance, could be construed to affect the structure or function of the body, and therefore would be classified as medical devices under the Federal Food, Drug and Cosmetic Act.  

Under the act, manufacturers of medical devices must obtain marketing clearance before offering them for sale. Meanwhile, cosmetic devices are governed by the Consumer Product Safety Commission.

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