Federal Register #FDA-2026-N-6732

FDA Classifies Foam or Gel Chemical Sterilant/High Level Disinfectant as Class II Medical Device

This FDA final order addresses the classification of foam or gel chemical sterilant/high level disinfectants as Class II medical devices: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Tristel Solutions Limited is referenced as the requester for De Novo classification (Tristel Duo ULT device) - Products/Services Requested: - Classification applies to foam or gel chemical sterilant/high level disinfectants intended for terminal high level disinfection of medical devices prior to patient use - No specific procurement of products or services is requested in this notice - Unique or Notable Requirements: - Devices must meet special controls including: - Non-clinical performance testing (demonstrating efficacy against pathogens) - Biocompatibility testing - Human factors testing - Detailed labeling for safe use, storage, and disposal - Demonstration of compatibility with medical devices - Classification aims to reduce regulatory burdens and improve patient access to innovative disinfection devices - No purchase quantities, part numbers, or procurement actions are specified in this notice

Description

The Food and Drug Administration (FDA) is classifying the foam or gel chemical sterilant/high level disinfectant into class II (special controls). This classification provides reasonable assurance of safety and effectiveness of the device and aims to enhance patient access to innovative devices by reducing regulatory burdens. The device is identified as a germicide in foam or gel form intended for high level disinfection of medical devices prior to patient use. Special controls include non-clinical performance testing, biocompatibility, human factors testing, and detailed labeling requirements.

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