As described below, you sell a product that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. 3 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 2 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded. In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) 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. Your product is also misbranded under section 502(o) 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. § 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. Accordingly, your product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. The “COVID-19 Fingerstick Test Kit” is offered for sale and distributed in the United States for at-home use without marketing approval, clearance, or authorization from FDA. FDA has observed that your website offers an at-home sample collection kit that can be sent to your firm for COVID-19 1 serology testing, specifically the “COVID-19 Fingerstick Test Kit.” Based on our review, this product is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people, and thus, it is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address on June 16, 2020. RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019

Issuing Office: Center for Devices and Radiological Health

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