Policy letter to U.S. Food and Drug Administration on FDA’s Software Precertification Program Working Model for software as a medical device

UCSF’s Center for Digital Health Innovation focuses on the area of real-world performance.  We discuss the significance of collecting and evaluating real-world performance data, what data to collect and evaluate, who to involve, and where to share and publish the results.  We also recommend adding “Interoperability” as a core principle of excellence, consistent with Congress’s findings in the 21st Century Cures Act, and lift up a model software precertification notice to promote transparency and understanding across all end-users and the general public.