Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
Key claim: The FDA is classifying the intraoral cooling device as a Class II medical device subject to special controls, determining this provides reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the intraoral cooling 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 intraoral cooling device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of 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 classification with special controls establishes the regulatory pathway for intraoral cooling devices — often used to mitigate oral side effects of chemotherapy or dental procedures — meaning new manufacturers can enter the market via 510(k) clearance rather than more burdensome premarket approval. For patients and providers, this typically expands access to the device category while relying on FDA-defined controls (labeling, performance testing) to manage safety risks.