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Open for CommentFDA· Food and Drug AdministrationProposed RuleFDA-2026-N-2590

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

Introduced March 30, 2026Comment period ends May 30, 2026View on regulations.gov ↗

What This Means

The FDA appears to be reclassifying tuberculosis cell-mediated immunity tests and related immunospot tests as microbiology devices. This would likely establish new premarket approval and quality standards.

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This proposal is not currently open for public comment.

Details

TypeFederal Regulation
AgencyFDA · Food and Drug Administration
DocketFDA-2026-N-2590
Regulations.gov IDFDA-2026-N-2590-0001
IntroducedMarch 30, 2026
Comment DeadlineMay 30, 2026