Lexology January 14, 2026
Last week, the U.S. Food and Drug Administration (“FDA”) rung in the new year with a flurry of device-related activity, updating two final guidance documents and withdrawing a guidance published back in 2017. The two final guidance documents released on January 6, 2026 pertain to (1) General Wellness Devices and (2) Clinical Decision Support Software, and supersede previous versions of those guidance documents.[1] Then on January 7, 2026, FDA withdrew its guidance entitled “Software as a Medical Device (SAMD): Clinical Evaluation.”[2]
This recent activity marks a significant shift in the FDA’s approach to the regulation of digital health and wellness technologies. With the release of two final guidance documents alongside the withdrawal of an older software guidance, the agency is...
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