FDA WARNING_LETTER - Workswell Group s.r.o. - February 19, 2021

The FDA issued a Warning Letter to Workswell Systems on March 5, 2021, following a review of their website (https://workswell-thermal-camera.com/) and social media pages on February 19, 2021. The letter addresses the sale of their "MEDICAS" product, a human body temperature measuring device, in the United States.

The FDA determined that the MEDICAS product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19, classifying it as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"). The product is deemed adulterated under section 501(f)(1)(B) of the Act because Workswell Systems lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. Furthermore, the product is misbranded under section 502(o) of the Act 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 FDA highlights the public health risks associated with unapproved telethermographic devices, including inaccurate temperature readings that could lead to non-adherence to infection control guidelines. Workswell Systems' website indicated the MEDICAS could scan multiple individuals simultaneously, exacerbating these risks.

The letter demands immediate action to cease the sale of these adulterated and