FDA WARNING_LETTER - Vivera Pharmaceuticals, Inc. - April 01, 2021

The FDA issued a Warning Letter to hometestbox.com on July 26, 2021, following website reviews on March 3 and April 1, 2021. The letter addresses the sale of the VIVERA + OMECARE Home Specimen Collection Kit (COVxHT Kit), marketed for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The FDA determined the COVxHT Kit is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). It is deemed 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). The kit 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 device into commercial distribution, as required by section 510(k).

The introduction or delivery of this product into interstate commerce is prohibited under section 301(a) of the Act, and misbranding after shipment in interstate commerce is prohibited under section 301(k). Given the public health emergency