FDA WARNING_LETTER - BTL Industries, Inc.

This FDA Warning Letter, addressed to BTL Industries Inc. of Bulgaria, identifies that the firm is marketing its BTL-5000 and BTL-6000 devices in the U.S. without the required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The FDA's Office of Compliance reviewed the firm's website and determined these products are medical devices. Specifically, the devices are deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) because BTL Industries Inc. lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). Furthermore, the devices are misbranded under section 502(o) of the Act (21 U.S.C. 352(o)) due to the firm's failure to submit a 510(k) premarket notification. As a result of these serious violations, the BTL-5000 and BTL-6000 devices are subject to refusal of admission into the U.S. under section 801(a) of the Act, potentially leading to "detention without physical examination." The FDA also advises U.S. federal agencies of such warning letters, which may impact contract awards, and states that PMA applications for Class III devices and requests for Certificates to Foreign Governments will not be granted until these violations are corrected. BTL Industries Inc. must provide a written response within fifteen working days detailing specific corrective actions, a plan to prevent recurrence, and a timetable for implementation, including documentation.