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EnMed MicroAnalytics, Inc. was selling COVID-19 sample collection kits (blood spot and saliva testing packets) through their website without FDA approval, clearance, or authorization, making the products adulterated under the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket approval (PMA) or investigational device exemption (IDE), and did not submit a 510(k) notification to FDA before distributing the devices, resulting in misbranding violations. These unauthorized COVID-19 diagnostic devices were being offered for sale and distributed in interstate commerce in violation of federal law.