FDA WARNING_LETTER - Meditherm Inc.

The FDA issued a Warning Letter to Meditherm, Inc. regarding their Meditherm Med2000 device (K003332). The FDA found the company is marketing the device for uncleared uses and making false/misleading claims, violating the Federal Food, Drug, and Cosmetic Act.

The Meditherm Med2000 was cleared in 2001 for thermal imaging to view and store thermal patterns of the human body. However, the company's website (meditherm.com) promotes uses beyond this clearance, including "diagnosis, treatment and prognosis," "early detection and monitoring of abnormal physiology" for breast cancer, and "increasing chances of detecting breast cancer in its earliest stages." These claims were previously deemed objectionable by the FDA during the 510(k) review. The website also lists 76 specific conditions, such as neoplasias and alcoholism, for which the device is promoted, which are outside its cleared indications.

These expanded claims constitute a major change to the device's intended use, requiring a new premarket notification (21 CFR § 807.81(a)(3)(ii)). Consequently, the device is adulterated under section 501(f)(1)(B) and misbranded under section 502(o) for failure to notify the FDA.

Furthermore, the device is misbranded under section 502(a) because