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

10 September 2026

In plain English

FDA classifies the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease as a class II medical device subject to special controls.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
10 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. We are taking this action because we have determined that classi
The full text is at the source

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