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    • MEDICAL DEVICES—FINAL RULES: FDA classifies von Willebrand factor assay
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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: FDA classifies von Willebrand factor assay, (Jun 3, 2026)

    By WK Editorial Staff

    The FDA classified the von Willebrand factor assay 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 von Willebrand fact ...

    By WK Editorial Staff

    The FDA classified the von Willebrand factor assay 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 von Willebrand factor assay. 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. 32336 (June 1, 2026)).

    Dates. The order is effective June 1, 2026. The classification was applicable on September 29, 2022.

    FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews SafetyNews

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