FDA WARNING_LETTER - Industry Lab Diagnostic Partners - December 01, 2020

On November 20, 2020, the FDA issued a Warning Letter to the company operating www.ildp.com after reviewing their website on July 20, 2020. The FDA observed that the firm offers a "COVID-19 Testing Kit," an at-home sample collection kit for nasopharyngeal nasal swabs intended for COVID-19 testing.

The FDA determined this kit is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h), because it is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The product is considered adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), as it is offered for sale and distributed without marketing approval, clearance, or authorization from FDA, lacking an approved premarket approval (PMA) or investigational device exemption (IDE).

Furthermore, the product is misbranded under section 502(o) of the Act, 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 51