Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The Covid-19 Self Detection Test Kits are offered for sale and distributed to consumers in the United States for self-testing without marketing approval, clearance, or authorization from FDA. Accordingly, the products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
Passage 2Your products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Passage 3Your website (noted above), includes statements indicating that the COVID-19 Self Detection Test Kits may be purchased directly by consumers and are intended to be used for self-testing for COVID-19, including: - "ACCURACY BUT FAST, EFFICIENT; ANYTIME, ANYWHERE AT YOUR PRIVACY AND CONVENIENCE." [https://www.biopolygen.com/shop/-Covid-19-antigen/c-p778] - "INSTANT AND EASY ACCESS TO SCREENING CAN BE LIFE OF[sic] DEATH. SCREENING FOR YOURSELF AND YOUR FAMILY TODAY AND REPEAT THE ROUTINE SCREENINGS TO PROTECT YOURSELF." [https://www.biopolygen.com/shop/-Covid-19-antigen/c-p778] - A photograph of the "COVID-19 Antigen and Antibody Combo Set" includes the following language: "SELF-SCREENING METHOD FOR EALRY PREVENTION AND EARLY TREATMENT." [https://www.biopolygen.com/shop/-Covid-19-antigen-antibodycombination/c-p783]