FDA Establishes Special Controls for Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System

The U.S. Food and Drug Administration (FDA) has issued a final order establishing special controls for the classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease. This regulatory action outlines specific requirements to ensure the safety and effectiveness of this clinical chemistry and clinical toxicology device.