Brain-Hematoma Imaging Devices Placed in Special-Control Category

Classification will provide “a reasonable assurance of safety and effectiveness of the device.”
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The U.S. government is placing brain-imaging devices that use “near-infrared” technology to detect hematomas into a special-control category that it says will provide “a reasonable assurance of safety and effectiveness of the device.”

On March 23, 2012, the Food and Drug Administration (FDA) posted a Federal Register notice—Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector—classifying near infrared (NIR) brain hematoma detectors as class II (special controls) devices.

NIR brain hematoma detectors are noninvasive devices using near-infrared spectroscopy to evaluate suspected brain hematomas, the FDA says. In addition, the FDA says it places medical devices into class II categories if existing general controls are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information that special controls will provide a reasonable assurance of the devices’ safety and effectiveness.

The FDA says that categorizing NIR brain hematoma detectors as class II devices—creating special controls—are necessary to mitigate health risks identified with the use of those devices. Those special controls are:

-- The sale, distribution and use of NIR brain hematoma detectors is restricted to prescription use

-- NIR hematoma detector labeling must include specific instructions and the clinical training needed for the safe use of the device

-- Appropriate analysis/testing should validate EMC, electrical safety and battery characteristics of the NIR hematoma detectors;

-- NIR hematoma detector performance data should validate accuracy and precision and safety features

-- Any elements of a NIR hematoma detector that may contact the patient should be demonstrated to be biocompatible;

-- Appropriate software verification, validation, and hazard analysis should be performed.

The rule becomes effective April 23, 2012, however, the classification of NIR brain hematoma detectors as class II became applicable on Dec. 13, 2011.

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