FDA loosens oversight of clinical decision support software and wellness wearables
On January 6, 2026, FDA Commissioner Marty Makary announced at the Consumer Electronics Show that the agency was relaxing oversight of some digital health products. The same day the FDA issued revised final guidance on clinical decision support (CDS) software, replacing its 2022 version, and on low-risk general wellness products. Under the CDS guidance, the FDA will generally not regulate software that gives clinicians a single recommendation, such as a specific drug to consider, if the software meets its other non-device criteria. The wellness guidance lets non-invasive wearables report readings such as blood pressure and blood glucose without FDA review, as long as they are marketed only for wellness and make no medical claims. The guidances were issued without a prior public comment period.
Why it's notable: More AI decision-support tools and consumer wearables can now reach clinicians and patients without FDA review, so validating them falls more on the health systems and clinics that adopt them.