The Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for the treatment of fibromyalgia symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the computerized behavioral therapy device for the treatment of fibromyalgia symptoms. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · June 26, 2026
FDA Classification of Computerized Behavioral Therapy Device for Fibromyalgia Symptoms as Class II
Original title: Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
FDA classifies computerized behavioral therapy devices for fibromyalgia into Class II with special controls, establishing regulatory pathway for this device type.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.