FDA warns device makers over unapproved claims

U.S. FDA recently released 2 warning letters to companies that it claims are marketing products for unapproved medical uses.

London-based Medical Specialties of California UK has sold its Penguin Cold Caps in the U.S. for the purpose of reducing hair loss for chemotherapy patients, according to FDA. Santa Ana, Calif.–Rapid Release Technologies has meanwhile gone beyond the claims of standard therapeutic vibrator and heat pad devices when it comes to its RRT PRO2, FDA said.

FDA is ordering both companies to stop distributing the products for the uses discussed in the warning letters.

Phone calls and emails to officials at both companies were not immediately returned.

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