FDA published revised final versions of two digital health guidances on January 6, 2026. Neither went out as a draft first. The clinical decision support guidance sits under Docket FDA-2017-D-6569 and the general wellness guidance under Docket FDA-2014-N-1039.
On CDS, the change that matters most is the single recommendation. The 2022 version treated software that gave one output rather than a list as a device function. The 2026 version allows enforcement discretion when a single recommendation is the only clinically appropriate option and the other criteria hold. Language stating that risk predictions automatically fail was deleted, so a cardiovascular risk score built on validated inputs can sit outside device oversight. Software predicting events inside a 24-hour window, guiding immediate escalation of care, or analysing images directly remains a device. The transparency criterion softened too: FDA now accepts a summary of the general approach and the most decision-relevant information rather than a full accounting of the algorithm.
On general wellness, FDA now says non-invasive sensing, including optical and motion-based methods, may estimate blood pressure, oxygen saturation, blood glucose and heart rate variability for wellness purposes. The product cannot name a disease, use clinical thresholds, style outputs as abnormal with warning colours or alarms, or claim to be clinical grade or a substitute for an authorized device. Anything implanted or invasive, microneedles included, is out.
Practitioners flagged the gaps quickly. Amanda Johnston of Gardner Law noted that "the law itself has not changed," and others asked what counts as clinically appropriate and how a product tells a user to see a doctor without characterizing a reading as abnormal. A startup relying on either policy should write the rationale down now, because enforcement discretion is a position, not an authorization, and it can move again without a comment period.