Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease

Published

Sep 10, 2026

Effective

Sep 10, 2026

Citation

91 FR 57493

Docket

Docket No. FDA-2026-N-9911

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) is reclassifying a diagnostic test that measures anti‑tumor necrosis factor‑alpha (anti‑TNF‑α) antibodies in patients with inflammatory bowel disease (IBD). By moving the test system into “Class II” – a category that requires specific performance standards called “special controls” – the agency aims to ensure the test is safe and effective while making it easier for manufacturers to bring innovative products to market. The special controls, now part of the official classification, set clear requirements for things like clinical data, labeling, and quality testing. This final rule is issued by the U.S. Department of Health and Human Services, through the FDA, and it applies to companies that develop, manufacture, or sell the anti‑TNF‑α IBD test system. Health‑care providers and patients will also be affected, because the reclassification is intended to increase confidence in the test’s reliability and expand access to the technology. The rule became effective on September 10, 2026, the same day it was published in the Federal Register (91 FR 57493). Because it is a final amendment, there is no further public comment period; the FDA will now enforce the new Class II classification and the associated special controls. Manufacturers must comply with those controls to market the test, and the agency will continue routine oversight to ensure ongoing safety and performance.

AI-generated summary — verify against the Federal Register text.

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