WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying an intraoral cooling device as a Class II medical device with special controls, a move that establishes regulatory requirements for technology designed to reduce the likelihood of oral mucositis in patients undergoing treatment. The action takes effect June 1, 2026, while the classification became applicable on Oct. 14, 2022. The agency said the decisio . . .

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