Data / Federal rules / 2026-06064
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
The Food and Drug Administration published this proposed rule in the Federal Register on March 30, 2026. Comments closed on May 29, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-06064
- Type
- Proposed rule
- Action
- Proposed amendment; proposed order; request for comments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 30, 2026
- Comments due
- May 29, 2026
- Dates
- Submit electronic or written comments on the proposed order by May 29, 2026. Please see section X of this document for the proposed effective date when the new requirements would apply and for the proposed effective date of a final order based on this proposed order.
- Docket
- Docket No. FDA-2026-N-2590
- Code of Federal Regulations
- 21 CFR 866
- Topics
- Biologics; Laboratories; Medical devices
- Pages
- 11
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on biologics · Rules on laboratories · Rules on medical devices · Published in March 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.