Opportunity
Federal Register #2026-10899
FDA Classifies Intraoral Cooling Device and Oropharyngeal Electrical Stimulator as Class II Medical Devices
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
June 01, 2026
Identifier
2026-10899
NAICS
334510, 339112
The Food and Drug Administration (FDA), through its Center for Devices and Radiological Health, has issued a final rule classifying two medical devices as Class II with special controls: - Intraoral cooling device: - OEM: BrainCool AB - Intended to cool the mouth and reduce the likelihood of oral mucositis - Features a removable mouthpiece that cools oral mucosal surfaces - Subject to special controls including: - Non-clinical performance testing - Electromagnetic compatibility and electrical safety testing - Software verification and validation - Biocompatibility evaluation of patient-contacting components - Specific labeling requirements (device specifications, usage instructions) - Oropharyngeal electrical stimulator: - OEM: Phagenesis Limited - Intended for oropharyngeal electrical stimulation - Classified as Class II with special controls to ensure safety and effectiveness - Both devices were previously classified as Class III but have been reclassified via De Novo requests, reducing regulatory burdens and enhancing patient access - No specific procurement quantities, part numbers, or purchase requirements are included, as this is a regulatory classification action, not a solicitation
Description
The Food and Drug Administration (FDA) is classifying the intraoral cooling device into class II with special controls. This device is a prescription use device intended to cool the mouth to reduce the likelihood of oral mucositis. The classification provides reasonable assurance of safety and effectiveness and aims to enhance patient access by reducing regulatory burdens. The device consists of a removable mouthpiece that cools the oral mucosal surfaces. Special controls include non-clinical performance testing, electromagnetic compatibility and electrical safety testing, software verification and validation, biocompatibility of patient contacting components, and specific labeling requirements.