We just returned from this year’s AHE Exchange and APIC conferences—two of the largest gatherings of healthcare environmental and infection prevention professionals. While we had many inspiring meetings and conversations, we saw a troubling trend: UV-C companies boldly marketing devices for use in healthcare settings without FDA Authorization. This isn’t just a regulatory oversight. It undermines patient safety, erodes trust, and weakens the very infection control standards these conferences aim to advance.
FDA now regulates all UV technologies marketed for pathogen reduction
Let’s be clear: if a UV company is promoting or selling devices for use in operating rooms, patient rooms, or other clinical environments where non-critical medical devices are present—without FDA Authorization—they’re crossing a regulatory line, and they know it. The FDA now regulates all UV technologies marketed for pathogen reduction in these settings under its Whole Room Microbial Reduction category.
This marks a significant regulatory shift—one that protects those like you, who prioritize safety, trust, and accountability in patient care. The era of ambiguity is over. The FDA has stepped in—and like it or not, the rules are changing.
No, UV Companies Can’t Just Pick the EPA Over the FDA
In the last couple of years, the FDA has taken decisive action to clarify how UV-C technologies used for whole room microbial reduction are regulated. These devices are now classified as Class II medical devices, and they must undergo the FDA’s rigorous 510(k) premarket notification process. This isn’t optional, it’s mandatory.
Some say they don’t “consider themselves” a medical device. But here’s the thing: they don’t get to make that determination. If your UV product claims to kill or reduce pathogens and operates in a healthcare setting, you are a medical device—and subject to the same premarket requirements as everyone else.
At AHE and APIC, we heard multiple UV-C companies boldly claim their devices fall under EPA jurisdiction—even as they actively marketed to hospitals and infection prevention professionals. But if you’re making microbial reduction or disinfection claims in healthcare environments, you’re marketing a medical device—and that falls squarely under FDA oversight. While the EPA regulates chemical disinfectants and certain UV devices for non-clinical settings, selling to hospitals with health-related claims is not exempt from FDA authority, no matter how it’s labeled.
Why It Matters
At Surfacide, we’ve invested significant time, resources, and transparency required to meet these new standards. Our Helios+ UV-C System is now the second and most recent UV-C system to receive FDA Authorization as a Class II medical device for Whole Room Microbial Reduction—and the only one to do it using continuous 254 nm germicidal UV light and three UV-C emitters operating simultaneously in a single cycle. This achievement speaks not only to the power of our system, but also to its flexibility and adaptability in real clinical environments.
This isn’t just about compliance. It’s about patient safety, trust, and the integrity of infection prevention protocols. Healthcare leaders deserve to know that the tools they’re investing in have been rigorously reviewed by FDA. That’s the value of FDA Authorization. That’s what raises the standard across our industry.
To the UV-C companies still sidestepping regulation, your time is up. The FDA is here and it isn’t going anywhere. And if we truly care about UV-C playing a meaningful role in infection prevention, we should welcome it.
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Gunner Lyslo is the Founder and CEO of Surfacide, the only company to offer a triple-emitter UV-C system (Helios+) now FDA Authorized as a Class II medical device for Whole Room Microbial Reduction.
