FDA WARNING_LETTER - Medica Outlet

The FDA issued a Warning Letter to Medica Outlet (www.medicaoutlet.com) after determining the firm is marketing various Teosyal dermal fillers in the United States without required marketing clearance or approval. These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The FDA found that Medica Outlet had not received clearance or approval before offering these devices for sale, constituting a violation. Consequently, the Teosyal products are deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) due to the absence of approved premarket approval (PMA) applications or investigational device exemptions (IDE). Furthermore, the devices are misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) because the firm failed to notify the agency of its intent to introduce them into commercial distribution, as required by section 510(k). Given these serious violations, the dermal fillers are subject to refusal of admission into the U.S. under section 801(a) of the Act. Medica Outlet must provide a written response within fifteen business days detailing corrective actions, preventative measures, and a timetable for completion, including documentation.