How Hospitals Can Identify and Confirm Regulatory Status for UV Devices

Our panelists explain how hospitals treat whole-room UV systems as medical devices rather than EPA “pesticidal devices.” EPA covers consumer/nonclinical disinfection tools; anything marketed for reducing pathogens in healthcare spaces must be FDA-cleared (De Novo or 510(k)). Before buying, the panelists suggest asking vendors for their FDA clearance number and verifying it in the FDA’s public device databases (search by company name or product name). Don’t rely on “EPA registered” claims—there are well-meaning but uninformed vendors and some bad actors, so check the paperwork.