FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES; CLASSIFICATION OF THE ANTI-TUMOR NECROSIS FACTOR ALPHA MONOCLONAL ANTIBODY TEST SYSTEM FOR INFLAMMATORY BOWEL DISEASE

WASHINGTON, Sept. 10 -- Food and Drug Administration has issued a rule called: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease.

The rule was published in the Federal Register on Sept. 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 classif...