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FDA Classifies Hyperhidrosis Skin Patch as Class II Device With Special Controls
July 01, 2026
WASHINGTON, July 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified a prescription skin patch for treating hyperhidrosis as a class II medical device with special controls.

The Food and Drug Administration has issued a final rule classifying the skin patch for treatment of hyperhidrosis as a Class II medical device with special controls, establishing regulatory requirements intended to provide reasonable assurance of safety and . . .

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