(a) Identification. A computerized behavioral therapy device for the treatment of fibromyalgia symptoms is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of fibromyalgia symptoms.

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

(1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use and include the following:

(i) Evaluation of improvement in the symptoms of fibromyalgia; and

(ii) Evaluation of relevant adverse events.

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

(3) Physician and patient labeling must include the following:

(i) Recommended treatment regimes, including frequency and duration of use; and

(ii) A summary of the clinical data for the device, including a discussion of adverse events.

[91 FR 38512, June 26, 2026]