Summary
Superseding final guidance recommending a risk-based approach to computer software assurance for computers and automated data-processing systems used in medical-device production or quality management systems. It updates and replaces FDA's September 2025 guidance to align with the Quality Management System Regulation.
Healthcare Implications
Medical-device manufacturers, including developers of AI-enabled devices, should update assurance, testing, documentation, and supplier-control practices for software used in production and quality management. The guidance supports proportionate validation while maintaining confidence that automated systems perform as intended.