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.
The 2022 guidance also made clear that the CDS exemption did not apply to software functions that produced a risk probability or risk score. However, the new guidance strikes this language and even includes an example of a risk score function in its list of examples of software functions that would be subject to enforcement discretion.
FDA also updated its General Wellness draft guidance concerning the classification of certain low-risk non-invasive wearable monitoring products as non-device general wellness products. Under the new guidance, FDA may consider products that use non-invasive sensing to estimate, infer, or output physiologic parameters (such as heart rate variability, blood glucose, oxygen saturation, or blood pressure) to be non-device general wellness products when the outputs are intended solely for wellness uses.
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