Federal Register #FDA-2026-N-4644

FDA Classifies Microbial Nucleic Acid Preservation and Circulating Tumor Cell Enrichment Devices as Class II

The FDA, part of the Department of Health and Human Services, has issued final classification orders for two medical devices to ensure safety and effectiveness while reducing regulatory burdens: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - Devices Classified: - Device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples - Consists of a container and reagents for stabilizing microbial nucleic acids for microbiome analysis in human specimens - Not intended for preserving morphology or viability of microorganisms - May also be indicated for sample collection - Circulating tumor cell enrichment device - Designed to enrich circulating tumor cells in clinical samples - Classified under Class II with special controls for safety and effectiveness - OEMs and Vendors: - No specific manufacturers or vendors are named in the classification orders - Unique Requirements: - Devices are subject to Class II special controls, including labeling, device description, warnings, and design verification/validation studies - Premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act apply - Place of Performance: - FDA Center for Devices and Radiological Health, Silver Spring, MD

Description

The Food and Drug Administration (FDA) is classifying a device designed to preserve and stabilize the relative abundances of microbial nucleic acids in clinical samples into class II with special controls. This device consists of a container and reagents intended to stabilize microbial nucleic acids for subsequent assessment of microbial populations in human specimens by validated assays. The classification aims to ensure safety and effectiveness while enhancing patient access by reducing regulatory burdens. The device is not intended for preserving morphology or viability of microorganisms and is subject to premarket notification requirements under section 510(k) of the FD&C Act.

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