Home › Recently closed › 2026-06064
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
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.
- Document type
- Proposed Rule
- Federal Register document number
- 2026-06064
- Published
- Mar 30, 2026
- Action
- Proposed amendment; proposed order; request for comments.
- Docket
- FDA-2026-N-2590
- Comments posted on Regulations.gov (at last check)
- 6
- CFR parts
- 21 CFR 866
- DATES section (from the document)
- 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.
- Topics (auto-tagged)
- Medical devices
Source: Federal Register API, document 2026-06064. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.