Medical Device Resource Corporation – FDA Warning Letter, Apr 9, 2012

On October 9, 2012, the FDA issued a Warning Letter to Medical Device Resource Corporation following an inspection from March 26 to April 9, 2012. The inspection determined that the firm manufactures the Aquavage Model AV2000 and 1200 Systems, which are medical devices.

The primary violation identified is that the firm is marketing these devices for uses not cleared by the FDA. While the Aquavage Systems were cleared via 510(k) (K092284) for "aspirating subcutaneous fatty tissue including autologous fat collection," the firm's websites (www.mdresource.com and www.aquavage.com) promote the devices for unapproved uses. These include "liposculpture, body contouring, buttock and breast augmentation and stem cells derived from adipose tissue," "breast reconstruction," "enhancement of male pectorals," "rejuvenation of the face," and as an "alternative to silicon breast implants." Comparative claims regarding procedure speed were also cited as requiring clinical data and a new 510(k).

These unapproved claims constitute new intended uses, requiring a new premarket notification submission under section 510(k) of the Act, per 21 CFR 807.81(a)(3). Consequently, the devices are deemed adulterated under section 501(f)(1)(B