Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
Key claim: FDA is classifying a lab test that measures anti-TNF-alpha monoclonal antibodies in inflammatory bowel disease as a moderate-risk (class II) device with special controls, a lighter path than class III that is meant to make similar tests easier to bring to patients.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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 classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
Classifying this IBD anti-TNF antibody test as Class II lowers the regulatory bar for lab tests that measure how patients respond to biologics like infliximab and adalimumab, which are commonly used for Crohn’s disease and ulcerative colitis. A 510(k) pathway with special controls, rather than PMA, tends to bring more competing tests to market faster, which can affect availability and pricing for therapeutic drug monitoring in IBD.