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HHS FDA Places Oropharyngeal Electrical Stimulator in Class II Device Category
June 04, 2026
WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying the oropharyngeal electrical stimulator as a Class II medical device subject to special controls, establishing a regulatory framework for technology intended to treat swallowing dysfunction. The action takes effect June 1, 2026, while the classification became applicable on Sept. 16, 2022. FDA said the decision is intended to provide reasonable assuranc . . .

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