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 Antibody Self Test Kit and COVID-19 Antigen Self Test Kit are offered for sale in the United States directly to consumers to self-test at home or outside of a healthcare setting without marketing approval, clearance, or authorization from FDA.
Passage 2your 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 3Your 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 4Your products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because your webpage represents that the COVID-19 Antibody Self Test Kit and COVID-19 Antigen Self Test Kit are “FDA Emergency Use Authorized” using the FDA logo. These representations create a false impression that your products have been authorized for emergency use by FDA and are misleading.