Yu Zhao's article, "Decoding FDA's Final PCCP Guidance," analyzes its impact on AI-driven medical devices and combination products.

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.

This article deciphers the new U.S. laws around Predetermined Change Control Plans (PCCP).

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