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 ] Practical challenges and best uses for PCCPs
• [34:55 ] Submitting PCCPs: Considerations and tips
• [45:30 ] Potential of PCCPs for non-software devices: 3D-printed knees case
• [52:40 ] FDA guidance and limitations for label changes
• [1:06:20 ] Final recommendations and quality system implications for PCCPs

Memorable Quotes:

• “PCCPs could allow us to get anticipated changes approved without a new market submission — but that isn’t a blank check. It’s a pre-validation of boundaries.” — Mike Drues

Top Takeaways:

1. Consider PCCPs for High-Impact Changes: PCCPs are valuable for anticipated changes to AI-driven or complex devices, potentially reducing regulatory delays.
2. Limit Scope for Efficiency: Keep PCCPs specific, with only a few anticipated changes, as this simplifies review and helps secure approvals faster.
3. Integrate PCCPs in QMS: Adding PCCP protocols to quality systems may streamline change implementation and regulatory compliance for future device iterations.

References:

• Mike Drues on LinkedIn
• FDA PCCP Guidance (2023 & 2024) on anticipated changes and market submissions

MedTech 101:

Predetermined Change Control Plan (PCCP): A regulatory tool from the FDA allowing manufacturers to gain pre-approval for anticipated changes to a medical device, simplifying future modifications. Initially created for AI-driven devices, PCCPs now apply to all device types.

Audience Engagement:

Have you considered or implemented a PCCP for your device? What changes would you include if you could pre-approve future modifications?

Feedback:

We’d love your thoughts on the PCCP framework! Email us at podcast@greenlight.guru with your feedback, questions, or ideas for future topics.

Sponsors:

Special thanks to Greenlight Guru — the industry’s eQMS & EDC platform designed for medical devices. Learn more about how Greenlight Guru can streamline your change management at greenlight.guru.