Yu ZhaoJul 129 min readarticlesData-Driven Trends In Predetermined Change Control PlansData-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.
Yu ZhaoOct 13, 20236 min readarticlesPart III: SaMD PCCP Implementation Beyond AIML: Considerations & ChallengesThis article provides tips and practical considerations for PCCP implementation.
Yu ZhaoOct 10, 202311 min readarticlesPart II: Deciphering New US Laws Around Predetermined Change Control PlanThis article deciphers the new U.S. laws around Predetermined Change Control Plans (PCCP).
Yu ZhaoOct 4, 20235 min readarticlesPart I: Medical Device Postmarket Change Controls and FDA 510(k) Software Modification GuidanceFDA's guidance on postmarket change controls for 510(k) software modifications ensures SaMD changes maintain safety and compliance.
Yu ZhaoSep 12, 20231 min readarticlesImplementing a PCCP for Class II SaMD Products Beyond AI/MLThis white paper provides a comprehensive analysis of the PCCP, with practical insights into implementation priorities and approaches.