Federal Register #FDA-2026-N-2590

FDA Proposes Reclassification of Tuberculosis Diagnostic Devices to Class II

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is proposing to reclassify certain tuberculosis diagnostic devices to streamline regulatory requirements and improve patient access. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Products/Devices Affected: - Qualitative Mycobacterium tuberculosis cell-mediated immune response assays (product code NCD) - Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests (product code OJN) - These are prescription in vitro diagnostic devices used to aid in the diagnosis of Mycobacterium tuberculosis infection by measuring interferon-gamma or cytokine production in response to stimulation antigens - Notable OEMs and Referenced Products: - QIAGEN: QuantiFERON-TB (P010033) - DiaSorin: LIAISON QuantiFERON-TB Gold Plus (P180047) - Oxford Immunotec: T-SPOT.TB (P070006) - Unique/Notable Requirements: - Devices will move from Class III (premarket approval) to Class II (special controls), requiring premarket notification (510(k)) - Special controls include labeling and validation requirements to ensure safety and effectiveness - The FDA is seeking public comments on this proposed regulatory change - No specific purchase quantities or direct procurement of products is included, as this is a regulatory action - Place of Performance/Contact: - FDA offices in Silver Spring, MD and Rockville, MD

Description

The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and immune response enzyme-linked immunospot tests, which are currently class III devices requiring premarket approval, into class II devices subject to special controls and premarket notification. This reclassification aims to provide reasonable assurance of safety and effectiveness while facilitating easier access to these diagnostic tools. The FDA is also proposing a new device classification regulation and requests public comments by May 29, 2026.

View original listing