FDA WARNING_LETTER - Thermavis - February 25, 2021

The FDA issued a Warning Letter to Thermavis regarding their "Multi-Person Thermal Screening Camera" sold in the United States via their website, thermavis.com. The FDA reviewed the website on December 14, 2020, and February 25, 2021.

The FDA determined the product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), because website statements, such as "assist organisations and workplaces prevent the spread of Covid-19" and "screening for elevated body temperatures, a well-known symptom of COVID-19," establish its intended use for mitigating, preventing, treating, diagnosing, or curing COVID-19.

The product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), as Thermavis lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the FDA of intent to introduce the product into interstate commerce as required by section 510(k) of the Act