FDA WARNING_LETTER - Biopolygen Corp. - August 10, 2021

On July 9, 2021, the FDA issued a Warning Letter to Biopolygen after reviewing their website on January 7, February 26, and June 30, 2021. The FDA observed the sale of "COVIGEN AG-1 Covid-19 Self Detection Kit," "COVIDEX AB-1 Covid-19 Self Detection Kit," and "COVID-19 Antigen and Antibody Combo Set" (collectively, "COVID-19 Self Detection Test Kits").

These products are considered devices under section 201(h) of the Act, 21 U.S.C. § 321(h), as they are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because Biopolygen lacks approved applications for premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failing to notify the FDA of their intent to introduce the devices into commercial distribution, as required by section 510(k) of the