AkivaMed Inc. – FDA Warning Letter, Jul 8, 2020

On July 23, 2020, the FDA issued a Warning Letter to AkivaMed, following a July 8, 2020 review of their website, www.akivamed.com. The FDA observed that AkivaMed was offering a "COVID-19 Antibody Rapid Test Kit" for sale directly to consumers for at-home use in the United States.

The FDA determined this product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), as it is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

The product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because AkivaMed lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), as the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S