Micro Current Technology, Inc. – FDA Warning Letter, Jul 22, 2009

On July 20-22, 2009, an FDA inspection of Bio-Therapeutic, Inc. in Seattle, Washington, identified that the firm manufactures and offers for sale the Bio-Therapeutic, Inc., Platinum Nano? Microcurrent System (bt-nano) and the Bio-Therapeutic, Inc., Bio-Ultimate Platinum? Microcurrent System (BUP). These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection revealed that the firm had not obtained marketing approval or clearance for the bt-nano and BUP devices prior to commercial distribution, constituting a violation of the law. Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act 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 devices are misbranded under section 502(o) of the Act because the firm failed to notify the FDA of its intent to introduce these devices into commercial distribution, as required by section 510(k).

The FDA requires prompt corrective action to address these violations. Failure to comply may result in regulatory actions including seizure, injunction, and/or civil money penalties. Federal agencies will be advised of this Warning Letter for contract