FDA WARNING_LETTER - Kogniz, Inc. - February 12, 2021

The FDA issued a Warning Letter to Kogniz, Inc. after reviewing their website, kogniz.com, on February 12, 2021. The letter states that the KOGNIZ TC20, a product offered for sale, is intended for human body temperature measurement and is therefore a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”).

The KOGNIZ TC20 is deemed adulterated under section 501(f)(1)(B) of the Act because it is offered for sale in the U.S. without required marketing approval, clearance, or authorization (PMA or IDE). It is also misbranded under section 502(o) of the Act because Kogniz, Inc. failed to notify the FDA of its intent to introduce this product into interstate commerce for commercial distribution, as required by section 510(k). The introduction or delivery of this product into interstate commerce is prohibited under section 301(a) of the Act.

The FDA highlighted public health risks associated with telethermographic devices, especially those scanning multiple individuals simultaneously, as indicated by Kogniz's website statements. Kogniz, Inc. must take prompt action to correct these violations and respond in writing within fifteen business days, detailing corrective actions, a timetable for implementation, and documentation. Failure to comply may result in