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HHS FDA Classifies Swallowable Constipation Treatment Device as Class II Medical Device
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 an orally ingested transient device for constipation as a Class II medical device subject to special controls, establishing a regulatory framework for a technology that uses an electric swallowable capsule. The action takes effect June 1, 2026, and codifies a classification that was first applied on Aug. 26, 2022. FDA said the classification provides re . . .

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