FDA WARNING_LETTER - sonrisa family dental - June 15, 2020

On June 15, 2020, the FDA reviewed www.mycovidtest19.com and www.facebook.com/Mycovid19Club.com, finding that the firm offers "Cellex Test Kit" and "Leccurate Test Kit" for at-home COVID-19 testing. These products are considered devices under 21 U.S.C. § 321(h) and are being sold without FDA marketing approval, clearance, or authorization. Consequently, the products are adulterated under 21 U.S.C. § 351(f)(1)(B) due to the absence of approved premarket approval (PMA) or investigational device exemption (IDE) applications. They are also misbranded under 21 U.S.C. § 352(o) for failing to provide the required 510(k) premarket notification. The introduction of these products into interstate commerce is prohibited (21 U.S.C. § 331(a)), and it is a prohibited act to misbrand devices held for sale after interstate shipment (21 U.S.C. § 331(k)). Furthermore, the products are misbranded under 21 U.S.C. § 352(a) because the website falsely claims "FDA approved" status and misuses the FDA logo, creating a misleading impression. The FDA demands immediate cessation of sales for these unapproved products. The firm must email [email protected] within 48 hours detailing corrective actions and preventative measures, with supporting documentation. Failure to comply may lead to legal action, including seizure and injunction, and the firm will be added to FDA's public list of companies selling fraudulent COVID-19 products.