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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the spinal muscular atrophy newborn screening test system, (Jun 12, 2026)

    By WK Editorial Staff

    The FDA believes the action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.

    The FDA is classifying the Spinal Muscular Atrophy newborn screening test system into class II (special con ...

    By WK Editorial Staff

    The FDA believes the action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.

    The FDA is classifying the Spinal Muscular Atrophy newborn screening test system into class II (special controls). The special controls that apply to the device type will be part of the codified language for classification of the Spinal Muscular Atrophy newborn screening test system. The FDA is taking action because it has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device (Final Rule, 91 Fed. Reg. 35384 (June 11, 2026)).

    Dates.This order is effective June 11, 2026. The classification was applicable on November 9, 2022.

    FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews

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