Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistMask Supply Store was warned for distributing unapproved medical devices, including surgical masks and protective face masks marketed with disease claims such as "Anti fungus," "Anti flu," "Anti-germ," and "for COVID-19 Prevention." The company failed to obtain required premarket approval or an investigational device exemption before selling these products, which the FDA determined were devices under federal law based on their intended use in diagnosing, treating, or preventing disease. The violations were identified during an FDA website review conducted on March 12, 2021, which revealed explicit medical claims that established the products' device status.