FDA WARNING_LETTER - Dr. Hettie Morgan

On May 29, 2015, the FDA issued a Warning Letter to Dr. Hettie Morgan regarding the marketing of Interfall Hydrogel Injection (Polyacrylamide). The FDA determined, through a review of the firm's website (www.hydrigelinjections.com), that the product is being marketed as a soft tissue filler for aesthetic purposes, including use in the face, lips, buttocks, and for breast, genital, and whole body shaping.

The FDA classified Interfall Hydrogel Injection as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). The firm has not received marketing clearance or approval for this device in the United States. This constitutes a violation of the Act, rendering the device adulterated under section 501(f)(1)(B) because there is no approved premarket approval (PMA) application under section 515(a) or an approved investigational device exemption (IDE) under section 520(g).

Furthermore, the device is misbranded under section 502(o) of the Act because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k). For devices requiring premarket approval, the 510(k) notification is satisfied when a PMA is pending.

The FDA requires Dr. Morgan to provide a