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Talk to a SpecialistTalk to a SpecialistCertify Global Inc. was cited for marketing two telethermographic devices—the SNAP XT PRO HID and InfinityX PRO—as medical devices for measuring human body temperature without FDA approval, clearance, or authorization. The products were found to be adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act for lacking approved premarket approval (PMA) or investigational device exemption (IDE) applications, and misbranded under section 502(o) for failing to submit a 510(k) notification before introducing the devices into interstate commerce. The FDA determined that use of telethermographic devices for body temperature assessment presents potentially serious public health risks, including the possibility of incorrectly detecting normal temperatures in individuals who may be febrile.