Lexion Medical LLC Warning Letter Details

Summary

Lexion Medical LLC was warned for marketing three medical devices—the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE Gas Evacuation Cannula—without FDA marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket approval (PMA) or investigational device exemption (IDE) authorization and did not submit a 510(k) notification to the FDA before introducing the devices into commercial distribution. The violations were particularly concerning because the devices were marketed for use in the mitigation, prevention, treatment, diagnosis, and cure of COVID-19, and the FDA discovered the unapproved marketing through the company's website and social media as recently as June 2021.