The news that the U.S. FDA has opened a new digital health office carries some significant expectations for stakeholders, expectations that may take time to meet. More than one participant in the Oct. 19 FDA listening session for the Digital Health Center of Excellence (DHCoE) called on the FDA to ensure that this new center provides more regulatory clarity regarding a number of products, a task that may be some time in coming, given the need to harmonize with other national and international regulatory entities.