§ 882.1935. Near Infrared (NIR) Brain Hematoma Detector.
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/us/cfr/t21/s§ 882.1935·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2)The labeling must include specific instructions and the clinical training needed for the safe use of this device;
(3)Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;
(4)Performance data should validate accuracy and precision and safety features;
(5)Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,
(6)Appropriate software verification, validation, and hazard analysis should be performed. [77 FR 16927, Mar. 23, 2012]