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

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

Now Viewing

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

Next, our panel digs into what “cleared by FDA” actually means—and why it matters now. As Liz explains, companies must prove safety and effectiveness with rigorous performance testing (kill curves, simulated-use, ozone, and biocompatibility assessments), and the pandemic-era flexibilities have ended, so devices making medical claims belong under FDA oversight. Sade L. Rolon, MBA, CMIP, CHESP, T-CHEST, T-CSCT, then highlights today’s reality on the ground: Hospitals own multiple UV systems purchased during the surge, often not FDA-cleared, with uneven maintenance and confusion over EPA and FDA roles. Her challenge to the field is blunt—move toward a common, enforceable standard so procurement, use, and outcomes align with best practice.