Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistUSA Medical LLC distributed SARS-CoV-2 Antigen Rapid Test kits (COVID-19 Tests) in the United States without obtaining required FDA marketing approval, clearance, or investigational device exemption, rendering the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company also failed to notify FDA of its intent to introduce the devices into commercial distribution as required by section 510(k), making the products misbranded. These compliance failures—distributing unapproved medical devices intended for COVID-19 diagnosis without proper premarket authorization—violated FDA regulations and prohibited the introduction or delivery of these products into interstate commerce.