Federal Register #FDA2026N9905

FDA Classifies Two Medical Devices as Class II with Special Controls

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final classification for two medical devices, establishing special controls to ensure safety and effectiveness. - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - Devices Classified as Class II (Special Controls): - Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease - Intended for in vitro diagnostic measurement to aid management of Crohn's disease and ulcerative colitis - Requires design verification and validation, labeling with limiting statements, and compliance with special controls - Mechanical deviation device for esophageal protection during cardiac ablation procedures - Designed to reduce esophageal injury by mechanically deviating the esophagus away from ablation energy - Requires clinical, animal, and non-clinical performance testing, sterility and biocompatibility validation, shelf life demonstration, and specific labeling - OEMs and Vendors: - No specific manufacturers or vendors are named; classification applies to all future devices meeting these descriptions - Products/Services Requested: - No procurement quantities or part numbers for purchase; classification enables future market entry via 510(k) premarket notification - Unique Requirements: - Special controls include rigorous performance testing, biocompatibility, sterility, shelf life, and labeling requirements - Devices must comply with these controls to be marketed under the less burdensome 510(k) process - Notable Impact: - Classification reduces regulatory burden and facilitates patient access to innovative devices

Description

The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures by mechanically deviating the esophagus away from the source of ablation energy. The classification aims to provide reasonable assurance of the safety and effectiveness of the device while reducing regulatory burdens and enhancing patient access to innovative devices. Special controls include clinical, animal, and non-clinical performance testing, sterility and biocompatibility requirements, shelf life validation, and specific labeling requirements.

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