Health / Medical Topics

    Device Package Insert Problem Evaluation Result

    Device packaging that is missing the insert or that contains an incorrect or inadequate insert (e.g. an insert with either the incorrect information or insufficient information). (Food and Drug Administration)




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    Testing the device's over-current protection circuitry for its response to situations of overload, short circuit, or ground fault.
    Specifies whether a device is available over-the-counter.
    The device software attempted to write data outside the allowed memory location.
    A process that involves designing, fabrication, assembly and/or processing of a device or device component.
    A problem with the device's ability to pass light energy.
    Inspection of objects or surfaces requiring magnification using an optical microscope.

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