FDA WARNING_LETTER - orvic - March 02, 2021

On February 26, 2021, the FDA issued a Warning Letter to a firm operating the website facemaskandppestore.com, following reviews on August 24, 2020, and January 29, 2021. The firm was found to be offering for sale in the United States a serology test, the "LUNGENE SARS-CoV-V-2 Covid-19 IgG/IgM Rapid Antibody Test Cassette," directly to consumers for at-home use.

This product is deemed a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h), due to its intended use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The FDA determined the product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), as the firm failed to notify the agency of its intent to introduce the