Final rule · 2026-18429

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery

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.