FDA WARNING_LETTER - Thermoteknix System Limited - February 22, 2021

The FDA issued a Warning Letter to Thermoteknix Systems Ltd. on March 4, 2021, following a review of their website and social media on February 22, 2021. The letter addresses the sale of their "FevIR Scan 2" product in the U.S., which is marketed for measuring human body temperature and intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined the FevIR Scan 2 is a device under section 201(h) of the Act. Violations include the product being adulterated under section 501(f)(1)(B) because Thermoteknix lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) as the firm failed to notify the FDA of its intent to introduce the product into interstate commerce as required by section 510(k). The introduction of these products into interstate commerce is prohibited under section 301(a).

The FDA cited specific claims from Thermoteknix's website and social media, such as "helping fight the spread of coronavirus" and "helping curb the spread of #COVID19," as evidence of the product's intended use for COVID-19. The letter highlights public health risks associated with unapproved telethermographic devices, including inaccurate temperature