Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistLepu Medical Technology was cited for offering three COVID-19 diagnostic test kits (a neutralization antibody test, a SARS-CoV-2 antigen rapid test, and a saliva antigen rapid test) for sale in the United States without FDA marketing approval, clearance, or authorization. The company violated the Federal Food, Drug, and Cosmetic Act by failing to obtain premarket approval (PMA) or investigational device exemption (IDE) authorization, rendering the products adulterated, and by neglecting to submit the required premarket notification (510(k)) to FDA, making them misbranded. The FDA determined that introducing or delivering these unapproved diagnostic devices into interstate commerce violated federal law.