FDA’s New Software Validation Requirements Explained
May 19, 2026
The FDA’s new software validation requirements are reshaping how healthcare technology is tested and approved. By shifting from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA), regulators now prioritize risk-based testing, real-world software reliability, automated validation, audit trails, and patient safety. Learn how the FDA’s modernized approach impacts medical apps, Software as a Medical Device (SaMD), digital health compliance, and the future of safe healthcare technology.