21 CFR §882.1935

1. (a)Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
   2. (2)The labeling must include specific instructions and the clinical training needed for the safe use of this device;
   3. (3)Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;
   4. (4)Performance data should validate accuracy and precision and safety features;
   5. (5)Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,
   6. (6)Appropriate software verification, validation, and hazard analysis should be performed.