(a) Identification. A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.

(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 model of therapy for the indicated gastrointestinal conditions;

(ii) Validate the model of therapy as implemented by the device using a clinically defined endpoint; and

(iii) Evaluate all adverse events.

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

(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(4) Labeling:

(i) 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 requirements that support the software of the device;

(iii) Patient and physician labeling must include a warning that the device is not intended for use in lieu of a standard therapeutic intervention or to represent a substitution for the patient's medication;

(iv) Patient and physician labeling must include a warning to seek medical care if a patient has feelings or thoughts of harming themselves or others; and

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

[88 FR 3636, Jan. 20, 2023]