Lexology January 12, 2026
On January 6, 2026, the US Food and Drug Administration (FDA) released updates to two guidance documents reflecting a move towards a more hands-off approach to digital health product regulation. Both updated guidance documents allow for more technologies to be commercialized without FDA premarket review. This move aligns with the agency’s efforts to soften its regulatory approach to promote more widespread usage of such products, especially AI-enabled products, and to bolster the speed at which they can be brought to market.
In Depth
New clinical decision support (CDS) software guidance
In the CDS software draft guidance, FDA presents its current thinking on the four criteria in Section 520(o)(1)(E) of the Food Drug and Cosmetic (FD&C) Act that a software function...
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