---
kind: "section"
citation: "21 C.F.R. § 882.1935"
title: "21"
number: "882.1935"
heading: "Near Infrared (NIR) Brain Hematoma Detector."
url: "https://uscodex.org/cfr/21/882.1935"
---

# §882.1935. Near Infrared (NIR) Brain Hematoma Detector.

- (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](/cfr/21/801.109.md) 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.**

## Notes

### 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]