FDA regulations | Bridging Consulting

Yu Zhao

Data-Driven Trends In Predetermined Change Control Plans

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

Yu Zhao

Yu Zhao Joins USC Delegation at International Regulatory Science Forum 2024

Yu Zhao delivered a plenary lecture and hosted workshops on FDA regulations at the International Regulatory Science Forum 2024.

Yu Zhao

Part II: Deciphering New US Laws Around Predetermined Change Control Plan

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

Yu Zhao

Implementing a PCCP for Class II SaMD Products Beyond AI/ML

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

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