Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistFast Masks USA LLC sold unauthorized COVID-19 test kits directly to consumers through its website, including at-home rapid antibody and antigen tests without FDA marketing approval, clearance, or authorization. The products violated the Federal Food, Drug, and Cosmetic Act by failing to obtain required premarket approval (PMA) or investigational device exemption (IDE) authorization, and by not notifying FDA of their intent to distribute medical devices under Section 510(k). The company's test kits were classified as adulterated and misbranded devices due to these compliance failures during the COVID-19 pandemic response period.