The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device 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 implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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 · September 10, 2026
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
FDA classifies the implanted tibial electrical urinary continence device into class II with special controls.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.