FDA WARNING_LETTER - Certify Global Inc. - February 09, 2021

The FDA issued a Warning Letter to the company operating certify.me after reviewing their website on February 9, 2021. The FDA observed that the website offers "SNAP XT PRO HID" and "InfinityX PRO" for sale, which are intended for measuring human body temperature. These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”).

The devices are considered adulterated under section 501(f)(1)(B) of the Act because the firm lacks approved applications for premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act as the firm failed to notify the FDA of its intent to introduce these products into interstate commerce for commercial distribution, as required by section 510(k). The introduction of these products into interstate commerce is prohibited under section 301(a) of the Act.

The FDA highlighted public health risks associated with telethermographic devices, including inaccurate temperature detection, especially when scanning multiple individuals simultaneously, which the company's website indicates its products are intended to do. The company must take prompt action to correct these violations. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties. The firm must respond in writing within fifteen business days, detailing corrective actions, a timetable for implementation, and documentation.