WASHINGTON, July 24 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified a diabetes digital behavioral therapeutic device as a Class II medical device with special controls, establishing a regulatory pathway intended to support patient access while maintaining safety and effectiveness standards.

The final amendment and final order took effect on July 24, with the classification applicable beginning July 7, 2023.

The ac . . .

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