FDA Declares Mouth-Cooling Gadget Officially Cool
Published Date: 6/1/2026
Rule
Summary
The FDA is officially putting the intraoral cooling device into class II, meaning it has special safety rules but fewer hurdles than the highest-risk devices. This change helps make sure the device is safe and effective while making it easier for patients to get this cool tech. The new classification is effective June 1, 2026, but it’s been in place since October 14, 2022, so manufacturers can plan ahead without extra costs.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
Device moved to Class II (special controls)
The FDA officially classified the intraoral cooling device into class II (special controls) effective June 1, 2026, with the classification applicable on October 14, 2022. FDA says this classification will provide reasonable assurance of safety and effectiveness and will enhance patients' access in part by reducing regulatory burdens.
Required safety and testing controls
Manufacturers must meet special controls: non-clinical performance testing (including thermal testing for cooling consistency and material integrity), electromagnetic compatibility and electrical safety testing, software verification/validation and hazard analysis for software components, biocompatibility of patient-contacting parts, and labeling that includes temperature cooling range, duration of cooling, and stop-use instructions.
Subject to 510(k) premarket notification
FDA states that intraoral cooling devices are subject to premarket notification requirements under section 510(k) of the FD&C Act and FDA has not determined the device type should be exempt under section 510(m).
Creates a predicate for future devices
Because FDA classified the device via the De Novo process, the intraoral cooling device can serve as a predicate for future devices of that type, allowing other sponsors to use the less burdensome 510(k) process to market substantially equivalent devices.
Device is prescription-only
The intraoral cooling device is identified as a prescription use device intended to cool the mouth to reduce the likelihood of oral mucositis. As a prescription device, it is subject to the prescription-device labeling rules referenced in the order.
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