BioElectronics Corporation – FDA Warning Letter, Jan 31, 2012

The FDA issued a Warning Letter to BioElectronics Corporation on January 31, 2012, for marketing ActiPatch, RecoveryRx, and Allay devices without marketing authorization, violating the Federal Food, Drug, and Cosmetic Act. The firm has an FDA-cleared 510(k) for the ActiBand device (K022404) for "treatment of edema following Blepharoplasty."

The FDA found that BioElectronics' websites (www.actipatchstore.com, www.allaystore.com, www.actipatch.ca, www.bielcorp.com) and device labeling for ActiPatch, RecoveryRx, and Allay include claims beyond the cleared indication for use of the ActiBand, representing major changes under 21 CFR 807.81(a)(3)(ii). Examples include ActiPatch for various pain therapies (back, wrist, knee, heel, elbow), inflammation, increased blood flow, and chronic wounds; RecoveryRx for breast plastic surgery, rhinoplasty, reducing swelling, bruising, pain, and accelerating healing; and Allay for menstrual pain, reducing swelling, and alleviating discomfort.

The FDA determined that premarket notifications for ActiPatch, Allay, and RecoveryRx were "not substantially equivalent" (NSE) to legally marketed devices. Therefore, these devices are adulterated under section 501(f)(1)(B