Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
- Published
- Sep 10, 2026
- Effective
- Sep 10, 2026
- Citation
- 91 FR 57504
- Docket
- Docket No. FDA-2026-N-9908
- Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
Final amendment; final order.
Summary
The Food and Drug Administration (FDA) has re‑classified the implanted tibial electrical urinary continence device as a Class II medical device. Class II status means the device can be marketed once it meets specific “special controls”—technical and performance standards the agency has identified to assure safety and effectiveness. The re‑classification is intended to provide reasonable protection for patients while easing the regulatory path for manufacturers, thereby helping bring innovative treatments for urinary incontinence to the market more quickly. The rule was issued by the FDA, the health‑product regulator within the U.S. Department of Health and Human Services. It applies to any company that designs, manufactures, or sells the implanted tibial electrical urinary continence device in the United States, as well as to health‑care providers who use the device in patient care. The final rule was published in the Federal Register on September 10, 2026, and it became effective the same day. Because the rule is final, there is no public comment period. Going forward, manufacturers must incorporate the identified special controls into their product development and submit the required pre‑market notifications (typically a 510(k) submission) demonstrating compliance before the device can be legally marketed.
AI-generated summary — verify against the Federal Register text.
Official abstract
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.
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