FDA WARNING_LETTER - Medakit Ltd - June 06, 2020

On June 10, 2020, the FDA issued a Warning Letter to Medakit Holdings Ltd. following a June 6, 2020, review of their website, www.medakit.com. The FDA observed that Medakit Holdings Ltd. was offering a serology test for at-home use, specifically the “COVID-19 Rapid Test Kit” (also known as “COVID-19 IgM/IgG Rapid Test” and “Covid-19 Fast Test Kit”), intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

The FDA determined that 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). The COVID-19 Rapid Test Kit is being sold and distributed in the United States without marketing approval, clearance, or authorization from the FDA.

Consequently, the product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks an approved premarket approval (PMA) application or an approved investigational device exemption (IDE). Furthermore, the product is misbranded under section 502(o) of the Act, 21 U