FDA WARNING_LETTER - Augustine Biomedical & Design, LLC

The FDA issued a Warning Letter to Augustine Biomedical & Design, LLC, for marketing the Hot Dog Patient Warming System with uncleared claims. The firm had obtained 510(k) clearances (K052392, K092807, K094056, K112488) for the device to prevent/treat hypothermia and provide warmth, primarily in hospitals and surgical centers.

However, a May 24, 2012, review of the firm's website (www.hotdog-usa.com) revealed claims of infection reduction, specifically "significant reduction in deep joint SSIs" and "74% reduction in implant infections," which are not supported by the existing 510(k) clearances. These claims constitute a major change in the device's intended use, requiring a new premarket notification (21 CFR 807.81(a)(3)(ii)).

Consequently, the Hot Dog Patient Warming System is deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) because it lacks an approved PMA or IDE. It is also misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) for failure