Federal Register #FDA-2026-N-9911

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

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final rule regarding the classification of a medical device for inflammatory bowel disease. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - ProciseDx, Inc. (OEM for Procise IFX and Procise ADL devices) - Products/Services Requested: - Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease - Intended for in vitro diagnostic measurement of anti-tumor necrosis factor alpha monoclonal antibodies - Aids in management of patients with Crohn's disease or ulcerative colitis - Devices referenced: Procise IFX, Procise ADL - Unique or Notable Requirements: - Device classified as class II medical device with special controls - Requirements include: - Design verification and validation - Analytical performance studies - Traceability to reference materials - Specific labeling statements for safety and effectiveness - No procurement or award is announced; this is a regulatory classification action.

Description

The FDA is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II with special controls. This device is an in vitro diagnostic intended to aid in the management of patients with Crohn's disease or ulcerative colitis. The classification aims to ensure safety and effectiveness while improving patient access by reducing regulatory burdens. The special controls include design verification, validation, and specific labeling requirements. This classification is effective from September 10, 2026.

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