Policy letter to U.S. Food and Drug Administration on FDA’s Software Precertification Program Working Model, version 0.2, for software as a medical device

UCSF’s Center for Digital Health Innovation focuses on the area of real-world performance.  Based upon our real-world experience, we recommend adding four subdomains to the FDA’s framework for real-world performance analytics, namely “real-world usage,” “workflow,” “interoperability,” and “universal design.”  We also expand upon our prior recommendation that the FDA develop and use a model software precertification notice for products with examples of why such transparency is so important to stakeholders and the public.