CoreMedica Laboratories, Inc. – FDA Warning Letter, Jun 18, 2020

On July 24, 2020, the FDA issued a Warning Letter to CoreMedica Laboratories regarding their "COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection & Transport Kit," offered on www.coremedicalabs.com and www.testmydrop.com. The FDA determined this product, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure, is a device under the Federal Food, Drug, and Cosmetic Act.

The product was offered for sale and distributed without FDA marketing approval, clearance, or authorization, rendering it adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) (21 U.S.C. § 352(o)) because the firm failed to notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) (21 U.S.C. § 360(k)). The introduction or delivery of this product into interstate commerce is prohibited under section 301(a) (21 U.S.C. § 3