(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.

[89 FR 71156, Sept. 3, 2024]