---
kind: "section"
citation: "21 C.F.R. § 882.5804"
title: "21"
number: "882.5804"
heading: "Computerized behavioral therapy device for the treatment of fibromyalgia symptoms."
url: "https://uscodex.org/cfr/21/882.5804"
---

# §882.5804. Computerized behavioral therapy device for the treatment of fibromyalgia symptoms.

- (a) **Identification.** A computerized behavioral therapy device for the treatment of fibromyalgia symptoms is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of fibromyalgia symptoms.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use and include the following:
    - (i) Evaluation of improvement in the symptoms of fibromyalgia; and
    - (ii) **Evaluation of relevant adverse events.**
  - (2) Software verification, validation, and hazard analysis must demonstrate that the device performs as intended.
  - (3) Physician and patient labeling must include the following:
    - (i) Recommended treatment regimes, including frequency and duration of use; and
    - (ii) **A summary of the clinical data for the device, including a discussion of adverse events.**

## Notes

### Amendments

[91 FR 38512, June 26, 2026]

### 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

[91 FR 38512, June 26, 2026]