What Separates Those Companies That Have Been FDA Authorized and Those That Haven’t?

EP: 1.FDA UV Authorization Introduction

EP: 2.When Did the FDA Begin Regulating UVC Robots?

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EP: 3.What Separates Those Companies That Have Been FDA Authorized and Those That Haven’t?

EP: 4.Modalities to Study the Efficacy of UVC Devices

EP: 5.FDA’s UV Performance Testing and Emergency Use Authorization for the COVID-19 Pandemic

EP: 6.Value Analysis Committees for UVC and What They Need

EP: 7.EPA Does Not Regulate Medical Devices, and UV Are Medical Devices

EP: 8.What Are the Differences Between Medical Devices and Nonmedical Devices?

EP: 9.Are These EPA-Regulated Since These Devices Are Dangerous to Staff?

EP: 10.What Is the Process to Get the FDA Authorization, and Is the FDA Enforcing this Industry?

EP: 11.Loopholes in the UV Device Industry

EP: 12.Where Can These Products Be Used if They Are Not (Yet) Authorized?

EP: 13.What Is Your One Piece of Advice to Health Care Leaders Evaluating These Devices?

EP: 14.Will the FDA Allow UV Companies to Market While Working on Getting the Authorization?

EP: 15.Educating the UV Device Purchaser

EP: 16.Panel Members’ Final Thoughts

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.