Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
- Published
- Sep 10, 2026
- Effective
- Sep 10, 2026
- Citation
- 91 FR 57502
- Docket
- Docket No. FDA-2026-N-9902
- Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
Final amendment; final order.
Summary
The Food and Drug Administration (FDA) has officially placed the cooperative powered surgical assist device used in ear, nose, and throat (ENT) operations into **Class II** of its medical‑device categories. Class II devices are subject to “special controls”—specific requirements such as performance testing, labeling standards, and quality‑system rules—that together are intended to ensure the device is safe and works as advertised. By giving the device this classification, the FDA believes it can protect patients while also making it easier for manufacturers to bring innovative tools to market without the heavier regulatory burden of a higher‑risk class. This rule was issued by the FDA, which is part of the U.S. Department of Health and Human Services. It directly affects companies that design, produce, or plan to market the cooperative powered surgical assist device for ENT surgery, as well as the surgeons who will use the equipment and the patients who will receive care with it. Manufacturers must now comply with the listed special controls—such as submitting a pre‑market notification (often called a 510(k)) and meeting specific labeling and performance criteria—before the device can be sold in the United States. The regulation was published in the Federal Register on **September 10, 2026** and became effective the same day. Because it is a final rule, there is no additional public comment period. Going forward, manufacturers will need to align their products with the new special‑control requirements, and the FDA will review compliance through its standard pre‑market and post‑market oversight processes.
AI-generated summary — verify against the Federal Register text.
Official abstract
The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery 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 cooperative powered surgical assist device for ENT surgery. 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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