Federal Register #FDA-2026-N-9909

FDA Classifies Whole Room Microbial Reduction Device as Class II Medical Device

This notice announces the FDA's final order classifying the whole room microbial reduction device as a Class II medical device. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEM Highlight: - Xenex Disinfection Services, Inc. is identified as the requester for the De Novo classification of the LightStrike+ device - Product/Service Details: - Device: Whole room microbial reduction device (e.g., LightStrike+) - Intended use: Reduces microbial load on medical device surfaces after cleaning and disinfection - No specific part numbers or quantities are provided - Unique/Notable Requirements: - Device classified as Class II under 21 CFR Part 880 - Special controls required, including: - Non-clinical performance testing - Biocompatibility evaluation - Software verification and validation - Labeling requirements - Classification aims to ensure safety and effectiveness, reduce regulatory burdens, and improve patient access to innovative devices - This is a regulatory classification action, not a procurement or award notice

Description

The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). This classification ensures the safety and effectiveness of the device and aims to improve patient access by reducing regulatory burdens. The device is intended to reduce microbial load on medical device surfaces following cleaning and disinfection. Special controls include non-clinical performance testing, biocompatibility evaluation, software verification, and labeling requirements. The classification became effective on September 10, 2026, with applicability starting September 1, 2023.

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