Two updated guidance documents aim to reduce “red tape” for certain digital health products.
On January 6, 2026, the Food and Drug Administration (FDA) issued updates to its guidance documents governing clinical decision support (CDS) software and general wellness devices. FDA Commissioner Marty Makary touted these changes as a way for FDA to “get out of the way as a regulator.” Department of Health and Human Services Secretary Robert F. Kennedy Jr. said the changes “[unlock] wearable devices for general wellness that have, for too long, been tied up in red tape.”
This Client Alert summarizes the key changes to FDA’s approach to these product offerings and examines broader industry considerations.
