U.S. FEDRegulation
FDA classifies focused ultrasound tissue ablation system as class II device
The Food and Drug Administration classified the focused ultrasound system for non-thermal, mechanical tissue ablation into class II with special controls. FDA determined that the classification will provide reasonable assurance of the device's safety and effectiveness. The agency said the action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. The order is effective October 6, 2026; the classification was applicable October 6, 2023.
Key points
- Focused ultrasound system for non-thermal, mechanical tissue ablation classified into class II.Federal Register
- Special controls identified in the order join the codified classification language.Federal Register
- FDA found class II will reasonably assure the device's safety and effectiveness.Federal Register
- Order effective October 6, 2026; classification applicable October 6, 2023.Federal Register
- The final order was published at 91 FR 63493 (FR Doc. 2026-20440).Federal Register
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RegulationU.S.FDA Final Order: Classification of Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation (Class II)HealthcareFor practitionersFor governance