§882.1935. Near Infrared (NIR) Brain Hematoma Detector.
21 C.F.R. § 882.1935
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.
Classification. Class II (special controls). The special controls for this device are:
The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
The labeling must include specific instructions and the clinical training needed for the safe use of this device;
Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;
Performance data should validate accuracy and precision and safety features;
Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,
Appropriate software verification, validation, and hazard analysis should be performed.
Notes, amendments, and revision history
Amendments
[77 FR 16927, Mar. 23, 2012]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.
Amendments
[77 FR 16927, Mar. 23, 2012]