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Product safetyFDAUnited StatesImports

Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device

10 September 2026

In plain English

FDA classifies the whole room microbial reduction device into class II, subject to special controls outlined in this order.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
10 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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
The full text is at the source

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