FDA WARNING_LETTER - Dubak Electrical Group - March 04, 2021

On March 4, 2021, the FDA issued a Warning Letter to Dubak Electrical Group regarding their "DuThermX" product, offered for sale on their websites (duthermx.com, dubakelectrical.com) and social media. The FDA reviewed these platforms on February 12, 2021, and determined that the DuThermX, a device for measuring human body temperature, is intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

This intent was established by statements such as "#covid19solutions…#covid19prevention" on Twitter and claims on their website about identifying elevated body temperature as a "key factor in mitigating the threat of illness" related to COVID-19.

The DuThermX is deemed an adulterated device under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because it lacks required premarket approval (PMA) or an investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(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 this product into interstate commerce