FDA classifies focused ultrasound system as class II
The Food and Drug Administration issued a final order classifying the focused ultrasound system for non-thermal, mechanical tissue ablation into class II with special controls, effective October 6, 2026. The order codifies the classification in 21 CFR 878.4405 and identifies the special controls that will provide reasonable assurance of safety and effectiveness.
Primary source
Federal Register rule, October 6, 2026
Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation
Read the source: Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation federalregister.gov
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