Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: FDA classifies mechanical deviation device as class II device, (Sep 14, 2026)

By WK Editorial Staff

The FDA is classifying the mechanical deviation 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 the order and will be part of the codified language for classification of the mechanical deviation device for esophageal protection during cardiac ablation procedures. The FDA stated it is taking this action because it has determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. The FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens (Final Rule, 91 Fed. Reg. 57495 (Sept. 10, 2026)).

Dates. This order was effective September 10, 2026. The classification was applicable on September 6, 2023.

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