Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures, (Sep 16, 2026)

By WK Editorial Staff

The FDA is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures 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 temperature regulation device for esophageal protection during cardiac ablation procedures. 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. (Final Rule, 91 Fed. Reg. 57500 (Sept. 10, 2026)).

Dates. This order is effective September 10, 2026. The classification was applicable on September 13, 2023.

FederalRegisterIssuances: FinalRules MDeviceNews