Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistWorkswell Group s.r.o. was cited for marketing the MEDICAS thermal imaging camera as a COVID-19 screening and diagnostic device without FDA authorization, making it an unadulterated and misbranded medical device. The company's website contained claims that the thermal camera could "detect virtually all types of viral diseases" including SARS-CoV-2 and could "diagnose a number of other illnesses," establishing intent to mitigate, prevent, treat, diagnose, or cure COVID-19 in violation of the Federal Food, Drug, and Cosmetic Act. The FDA identified these violations through review of the company's website and social media pages directing U.S. consumers to purchase the product without required premarket approval or clearance.