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BioWorld - Thursday, July 30, 2026
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Home » FDA’s new general wellness guidance is no dramatic overhaul
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FDA’s new general wellness guidance is no dramatic overhaul

Jan. 8, 2026
By Mark McCarty
The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was expecting a clear break with the 2019 version of the guidance was almost certainly disappointed.
Medical technology Regulatory Digital health U.S. FDA

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