The FDA’s Updated Approach to Wellness Tech: A Closer Look

The FDA’s Updated Approach to Wellness Tech: A Closer Look

FDA wellness device guidance 2026

The U.S. Food and Drug Administration (FDA) released its 2026 guidance on Low-Risk General Wellness Devices on January 6, replacing the 2019 version and bringing much-needed clarity to how wellness technologies should be designed and marketed in today’s digital health ecosystem. The document is short, but its implications stretch across fitness bands, smartwatches, health apps, […]

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