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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System, (Aug 27, 2025)

    By WK Editorial Staff

    The FDA has classified the pharmacogenetic assessment system into class II (special controls).

    The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the pharmaco ...

    By WK Editorial Staff

    The FDA has classified the pharmacogenetic assessment system into class II (special controls).

    The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the pharmacogenetic assessment system. The FDA is taking this action having 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, 90 Fed. Reg. 40704 (August 21, 2025)).

    Dates. This order is effective August 21, 2025. The classification was applicable on October 31, 2018.

    FederalRegisterIssuances: FinalRules MDeviceNews

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