Policy letter to U.S. Food and Drug Administration on FDA’s Software Precertification Program Working Model, version 1.0, 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 renew our recommendation to add four subdomains to the FDA’s framework for real-world performance analytics, namely “real-world usage,” “workflow,” “interoperability,” and “universal design.” Congress identified interoperability as a national priority in the 21st Century Cures Act, and we highlight interoperability analytics based on groundbreaking work in the National Quality Forum’s Interoperability Measurement Framework. We recommend, too, that the FDA require instrumenting of SaMD products to collect and analyze real-world performance data and analytics, without precluding use of alternative data sources as well. Lastly, we iterate our prior recommendation that the FDA develop and use a model software precertification notice for products to provide transparency, with examples of why such transparency is so important to stakeholders and the public.