Data-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.

This article provides tips and practical considerations for PCCP implementation.

FDA's guidance on postmarket change controls for 510(k) software modifications ensures SaMD changes maintain safety and compliance.

This white paper provides a comprehensive analysis of the PCCP, along with practical insights into implementation priorities and approaches

Yu Zhao co-hosted a panel on AI-based medical device regulations at MedCon 2022, discussing EU AI Act and U.S. FDA framework for SaMD.