Why UV Devices Used in Hospitals Are Regulated by the FDA

Dozens of UV vendors crowd the market, but only 2 devices are FDA-cleared for whole-room microbial reduction—setting a new bar for what “legal to market” actually means. In this segment, Elizabeth Claverie, a former FDA leader, explains the de novo and 510(k) pathways and why products making microbial-reduction claims are medical devices that must be cleared before hospitals buy or use them. Sade L. Rolon, MBA, CMIP, CHESP, T-CHEST, T-CSCT, an EVS operations expert, then spotlights the on-the-ground reality: pandemic-era fleets, uneven awareness, and the urgent need for shared criteria and education to get programs compliant.