(a) Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.

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

(1) Clinical data must be provided to fulfill the following:

(i) Describe a validated model of behavioral therapy for the psychiatric disorder; and

(ii) Validate the model of behavioral therapy as implemented by the device.

(2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.

(3) The following labeling must be provided:

(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 compatible devices.

(iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.

(iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.

(v) Physician labeling must include a summary of the clinical testing with the device.

[82 FR 61167, Dec. 27, 2017]