Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
Passage 2Your product is 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 device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Passage 3the COVID-19 Test Kit is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. The COVID-19 Test Kit is not authorized, so statements on your website that imply that the product is authorized are false. In addition, your website, https://www.anytimecovidtest.com, displays a large FDA logo near the top of the page. The FDA logo is positioned near images of and information about the COVID-19 Test Kit. The unauthorized use of the FDA logo***4*** alongside product information is misleading because it implies FDA approval, clearance, authorization, endorsement, or other evaluation of the COVID-19 Test Kit. Your website also displays a “Clinical Trials Number” (embedded within the FDA logo) that is positioned alongside images of and information about the product. Based on our review of your website and as described above, you are marketing the COVID-19 Test Kit for use at home as opposed to merely providing information about its investigational status. Further, your display of the clinical trial number is misleading because the representation fails to convey to consumers that the product is investigational and lacks approval, clearance, or authorization, and it also implies FDA approval, clearance, authorization, endorsement, or other evaluation of the product.