Near Infrared Brain Hematoma Detectors Classified as Class II Medical Devices by FDA

The US Food and Drug Administration (FDA) issued a final rule classifying Near Infrared (NIR) Brain Hematoma Detectors as class II medical devices requiring special controls on 22 March.

The rule is in response to a petition issued by InfraScan Inc., which asked FDA to classify its Infrascanner Model 1000 device-previously found by FDA to be class III-as a class II device instead.

FDA agreed with their assessment, and identified the inherent risks of the device and mitigation measures to reduce those risks.

All firms submitting 510(k) premarket notification for NIR Brain Hematoma Detectors need to henceforth comply with the special controls, said FDA.

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FDA - Medical Devices; Neurological Devices: Classification of the Near Infrared Brain Hematoma Detector