§ 880.5735 — Diabetes digital behavioral therapeutic device.

§ 880.5735 Diabetes digital behavioral therapeutic device.

(a) Identification. A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.

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

(1) Design verification and validation must include documentation of:

(i) Clinical data from a statistically and clinically justified sample size, fulfilling the following:

(A) Appropriately validating the model of therapy as implemented by the device using a clinically defined endpoint, and

(B) Demonstrating that use of the device does not adversely impact the health outcomes or health status of the intended use population. A device hazard analysis must consider all device-related adverse events observed from the clinical data collected and must demonstrate that patient risk from use of the device is minimal.

(ii) Software verification, validation, and hazard analysis must demonstrate that the device performs as intended.

(2) The labeling must include:

(i) A summary of the clinical testing with the device, including a discussion of the limitations of the clinical significance of the results.

(ii) Limiting statements that indicate:

(A) The device is not intended for use as a standalone therapy.

(B) The device is not a substitute for a patient's prescribed therapy or medication.

(C) The device should not be used by people with unstable psychiatric disorders.

(D) The device is not intended for use in the treatment of any psychiatric disorder or symptoms.

[91 FR 46721, July 24, 2026]