---
kind: "section"
citation: "21 C.F.R. § 890.5800"
title: "21"
number: "890.5800"
heading: "Virtual reality behavioral therapy device for pain relief."
url: "https://uscodex.org/cfr/21/890.5800"
---

# §890.5800. Virtual reality behavioral therapy device for pain relief.

- (a) **Identification.** A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display that utilizes a software program containing the behavioral therapy content.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events.
  - (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (3) Software verification, validation, and hazard analysis must be performed.
  - (4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
  - (5) Labeling must include the following:
    - (i) A warning regarding the risk of nausea and motion sickness;
    - (ii) A warning regarding the risk of discomfort from the device; and
    - (iii) **A summary of the clinical testing with the device.**

## Notes

### Amendments

[88 FR 985, Jan. 6, 2023]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

### Amendments

[88 FR 985, Jan. 6, 2023]