EPA Does Not Regulate Medical Devices, and UV Are Medical Devices

EP: 1.FDA UV Authorization Introduction

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

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

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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

Our panelists explain how hospitals treat whole-room UV systems as medical devices, not EPA “pesticide 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.