Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
Key claim: FDA is putting cooperative powered surgical assist devices used in ear, nose, and throat surgery into class II with special controls, so they can be marketed under a lighter path than class III while still meeting safety and effectiveness requirements.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Class II with special controls lets manufacturers of ENT cooperative powered surgical assist devices clear the FDA via 510(k) rather than the more burdensome PMA process, which typically shortens time to market. For patients and ENT surgeons, this means faster potential access to surgeon-guided powered assist tools, with safety and effectiveness assurance handled through device-specific special controls rather than pre-market approval.