FDA Blesses Room-Wide Germ Annihilation Devices
Published Date: 9/10/2026
Rule
Summary
The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the whole room microbial reduction device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Device moved to Class II rules
FDA has classified the whole room microbial reduction device as Class II (special controls). The device is subject to premarket notification under section 510(k) and must meet special controls such as non-clinical performance testing, biocompatibility testing, software verification and validation, electromagnetic and electrical safety testing, and labeling.
Creates a 510(k) predicate pathway
Because FDA granted De Novo classification, the whole room microbial reduction device can serve as a predicate for future devices, allowing other sponsors to use the less-burdensome 510(k) process instead of De Novo or premarket approval. FDA received the De Novo request on February 1, 2023, and issued the classification order on September 1, 2023.
Required safety testing and labeling rules
The rule requires specific safety and performance controls: testing for microbial log reduction, simulated worst-case and in-use performance, photobiological lamp safety, material compatibility, biocompatibility, software verification and validation, electromagnetic and electrical safety, and labeling. Labels must include warnings and instructions to ensure the device is operated in an unoccupied environment, setup and positioning instructions, and information about material compatibility.
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Key Dates
Department and Agencies
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