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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: FDA classifies ultrasound labeling device, (Jun 3, 2026)

    By WK Editorial Staff

    The FDA classified the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia into class II (special controls).

    The special controls that apply to the device type are identified in the order and will b ...

    By WK Editorial Staff

    The FDA classified the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia 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 real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia. The FDA took this action because it had determined that classifying the device into class II will provide a reasonable assurance of 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. 32338 (June 1, 2026)).

    Dates. The order is effective June 1, 2026. The classification was applicable on October 18, 2022.

    FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews SafetyNews

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