---
kind: "section"
citation: "21 C.F.R. § 882.5803"
title: "21"
number: "882.5803"
heading: "Digital therapy device for Attention Deficit Hyperactivity Disorder."
url: "https://uscodex.org/cfr/21/882.5803"
---

# §882.5803. Digital therapy device for Attention Deficit Hyperactivity Disorder.

- (a) **Identification.** A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate and document the following under the labeled conditions for use, which include considerations for the ability of the device to:
    - (i) Use a validated measure to evaluate effectiveness of device to provide therapy for ADHD or any of its individual symptoms; and
    - (ii) **Capture all adverse events.**
  - (2) Software must be described and provided in a clear and detailed manner to include 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 items:
    - (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 (OS) 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 standalone 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

[89 FR 71156, Sept. 3, 2024]

### 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

[89 FR 71156, Sept. 3, 2024]