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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: FDA classifies clinical mass spectrometry microorganism identification and differentiation system, (Jun 17, 2025)

    By WK Editorial Staff

    The Food and Drug Administration is classifying the clinical mass spectrometry microorganism identification and differentiation system into class II (special controls).

    The special controls that apply to the device type are identified in this order an ...

    By WK Editorial Staff

    The Food and Drug Administration is classifying the clinical mass spectrometry microorganism identification and differentiation 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 the clinical mass spectrometry microorganism identification and differentiation system’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens (Final Rule, 90 Fed. Reg. 24964 (June 13, 2025)).

    Dates. This order is effective June 13, 2025. The classification was applicable on April 20, 2018.

    FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews

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