May 2023

A major UV disinfection company announced their recent De Novo petition with the U.S. Federal Drug Association (FDA) for medical device market authorization of their UV room disinfection technology.

The FDA defines a De Novo request as providing “a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.”

The company uses a xenon lamp to create a broad spectrum UV light that kills pathogens on healthcare facility surfaces. Microorganisms the device is effective against include methicillin-resistant Staphylococcus aureus (MRSA), Clostridioides difficile (C. diff), and Vancomycin-resistant Enterococci (VRE).

Petitioning for a De Novo request allows the UV Company to enter an untapped product area and market their UV device as a medical device.

The UV disinfectant devices market saw a vast increase in demand and innovation due to the pandemic. Should this De Novo petition be accepted, we anticipate an even larger industry shift.

If you are interested in learning more about antimicrobial device testing, please contact our lab.