Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCreativeStar Solutions marketed thermal imaging devices (Artemis TI-CS-T11 Thermal Scanner and Artemis Gateway) as COVID-19 prevention solutions without FDA approval, making the products adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. The company violated premarket approval requirements by failing to obtain PMA clearance or IDE authorization before distributing the devices in the U.S., and also failed to submit the required section 510(k) notification to notify FDA of their intent to introduce these products into interstate commerce. The violations were identified during an FDA review of the company's website in February 2021, which contained explicit claims that the thermal scanners could be "used as a prevention solution for COVID-19."