Regulatory Determination: Whole Room Microbial Reduction Device
The Food and Drug Administration (FDA) has formally classified the whole room microbial reduction device into class II (special controls) under 21 CFR 880.6510. This final order, effective September 10, 2026, concludes the De Novo classification process initiated by Xenex Disinfection Services, Inc. By establishing this classification, the FDA provides a regulatory pathway that avoids the automatic class III designation for post-amendment devices, thereby facilitating market access through the 510(k) premarket notification process.
Compliance requires adherence to specific special controls designed to mitigate risks associated with chemical exposure, electrical hazards, and device failure. Manufacturers must conduct comprehensive non-clinical performance testing, including simulated and real-world use evaluations, to demonstrate microbial log reduction and photobiological safety. Furthermore, software verification, electromagnetic compatibility, and biocompatibility assessments are mandatory to ensure patient and operator safety in clinical environments.
| Identified Risk | Required Mitigation Measures |
|---|---|
| Chemical/Agent Exposure | Non-clinical performance testing; biocompatibility evaluation; labeling |
| Respiratory/Pulmonary Damage | Non-clinical performance testing; biocompatibility evaluation |
| Cross-Contamination | Non-clinical performance testing; labeling; software validation |
| Electrical Shock | Electrical safety testing; non-clinical performance testing; labeling |
| Device Interference | Electromagnetic compatibility; electrical safety testing; labeling |
Table of Contents
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUMMARY
DATES
SUPPLEMENTARY INFORMATION
I. Background
II. De Novo Classification
TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES FOR WHOLE ROOM MICROBIAL REDUCTION DEVICES
III. Analysis of Environmental Impact
List of Subjects in 21 CFR Part 880
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES