Global Medical Device Podcast Powered By Greenlight.guru

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices, providing a way for manufacturers to get pre-approval for certain future device changes. Etienne and Mike explore the origins of PCCPs, the intricacies of implementing them, and how this regulatory tool may allow for faster device modifications without additional market submissions. They also examine the benefits and limitations of PCCPs for both AI-driven and physical medical devices and provide practical tips for incorporating this into regulatory and quality management strategies.Key Timestamps:[03:15] Introduction to PCCPs and Change Management[08:40] PCCP’s origin and application for AI-driven devices[14:20] Expansion of PCCPs to all medical devices[25:10] Pr