What Is the Process to Get the FDA Authorization, and Is the FDA Enforcing this Industry?

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

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?

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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

The moderator was stunned by the sheer number of UV “robots” on display at conferences—and left with a simple question: How can hospitals tell which devices are truly authorized and which are not? That confusion is exactly why we convened this roundtable: to clarify the FDA pathway, help vendors and buyers understand that authorization is essential, and guide health systems toward compliant, defensible choices. With that in mind, our next topic is enforcement: What is the FDA actually doing now, and what should happen to curb the marketing and sale of unregulated devices?