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    Health Law Daily Wrap Up, Medical Devices—FINAL RULES: FDA classifies medial knee implanted shock absorber, (Jul 6, 2026)

    By WK Editorial Staff

    The FDA classified the medial knee implanted shock absorber 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 medial kne ...

    By WK Editorial Staff

    The FDA classified the medial knee implanted shock absorber 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 medial knee implanted shock absorber. 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. 39007 (June 29, 2026)).

    Dates. The order is effective June 29, 2026. The classification was applicable on April 10, 2023.

    FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews SafetyNews

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