Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
Key claim: The FDA has classified whole-room microbial reduction devices as Class II medical devices with special controls, giving manufacturers a defined, less burdensome path to market these products.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Classification of whole-room microbial reduction devices as Class II establishes a defined regulatory pathway for products marketed to hospitals, long-term care facilities, and other settings seeking to reduce airborne and surface microbial contamination. The 510(k) pathway with special controls lowers the market-entry burden compared to Class III premarket approval, which can affect the pace and price at which such devices reach care settings.