---
kind: "section"
citation: "21 C.F.R. § 882.5705"
title: "21"
number: "882.5705"
heading: "Digital therapy device to reduce sleep disturbance for psychiatric conditions."
url: "https://uscodex.org/cfr/21/882.5705"
---

# §882.5705. Digital therapy device to reduce sleep disturbance for psychiatric conditions.


(a) Identification. A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post-traumatic stress disorder.

(b) Classification. Class II (special controls). The special controls for this device are:

- (1) Clinical performance testing under the labeled conditions for use must evaluate the following:
  - (i) The ability of the device to provide therapy for patients with sleep disturbance due to psychiatric conditions, using a validated measure;
  - (ii) Worsening of any condition-specific symptoms using a validated measure for assessment of the particular condition; and
  - (iii) **Increase in symptoms of disturbed sleep or sleepiness using a validated measure.**
- (2) Software must clearly describe all features and functions of the software implementing the digital therapy. Software verification, validation, and hazard analysis must also be provided.
- (3) The labeling must include the following:
  - (i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device;
  - (ii) Patient and physician labeling must list the minimum operating system and general purpose computing requirements that support the software of the device;
  - (iii) Patient and physician labeling must include a warning that the digital therapy device is not intended for use as a stand-alone therapeutic device;
  - (iv) Patient and physician labeling must include a warning that the digital therapy device does not represent a substitution for the patient's medication; and
  - (v) Physician labeling must include a summary of the clinical performance testing conducted with the device.

## Notes

### Amendments

[88 FR 2223, Jan. 13, 2023]

### 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

[88 FR 2223, Jan. 13, 2023]