Omnisense Systems Pte Ltd. – FDA Warning Letter, Mar 4, 2021

On March 4, 2021, the FDA issued a Warning Letter to Omnisense Systems Pte Ltd and Omnisense Systems USA Inc. following a February 18, 2021, review of their website, https://www.omnisense-systems.com/. The FDA observed the sale of the "Sentry MK4" product, intended for measuring human body temperature, with claims suggesting its use for mitigating, preventing, treating, diagnosing, or curing COVID-19.

The FDA determined that the Sentry MK4 is 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 the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). 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 for commercial distribution, as required by section 510(k).

The Warning Letter cites specific website statements establishing the Sentry MK4's intended COVID-19-related use, such as "From H1N1, MERS, Ebola and now COVID-19, our fever detection system have been the trusted solution..." and "At the forefront of