Final rule · 2025-08145

Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device

The Food and Drug Administration (FDA, Agency, or we) is classifying the microbial nucleic acid storage and stabilization 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 the microbial nucleic acid storage and stabilization device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.