Business · 10/09/2026

FDA Classifies Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease into Class II

The FDA is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into Class II, which will provide a reasonable assurance of safety and effectiveness, and reduce regulatory burdens, thereby enhancing patients' access to innovative devices.