Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests

Document 2026-06064 is a Proposed Rule published by the Department of Health and Human Services in the Federal Register on March 30, 2026. The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. View the original at https://www.federalregister.gov/documents/2026/03/30/2026-06064/microbiology-devices-reclassification-of-mycobacterium-tuberculosis-cell-mediated-immunity-tests-and.

No. Document 2026-06064 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.