LTR 64: Opportunities and challenges to leverage PCCP for speed to market

Summary

“PCCP is a great tool for your regulatory strategy but it is not for every company or for every change”.

PCCP (Predetermined Change Control Plan) is a new regulatory scheme that allows device manufacturers to implement post-market changes without requiring pre-market submission to the FDA.

In this episode, Yu Zhao explains how the PCCP tool offers the advantage of reducing regulatory burden and speeding up the time to market. PCCP is particularly important for software and AI/ML-based medical devices due to the fast pace of innovation and the need for adaptive machine learning algorithms.

In a broader sense, PCCP really is part of the change management process, and risk management team plays a critical role in the development and implementation of PCCPs, as they help analyze potential benefits and risks.

Chapters

00:00 Introducing Yu Zhao

01:20 Definition and significance of PCCP

05:20 History and adoption of PCCP

08:59 Analysis of FDA data on authorized PCCPs

11:27 Key elements of a PCCP

15:17 Considerations for including changes in a PCCP

18:51 Role of risk management professionals in PCCP

21:29 Inclusion of PCCP in the design and development process

23:03 Cost-benefit analysis and resource allocation for PCCP

25:02 Insights from Yu Zhao's white paper on PCCP

27:36 Advice for career growth in the industry

30:13 Critical moments in Yu Zhao's career journey

33:20 Closing remarks on the benefits of PCCP

Suggested links:

1. PCCP White Paper - Implementing a PCCP for Class II SaMD Products Beyond AI/ML

2. PCCP Data Analysis: Data-Driven Trends in Predetermined Change Control Plans

3. FDA Draft Guidance for PCCP in AI/ML: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Key Takeaways

• PCCP is a new regulatory scheme that allows device manufacturers to implement post-market changes without additional marketing submissions to the FDA.

• PCCP is particularly important for software and AI/ML-based medical devices due to the fast pace of innovation and the need for adaptive machine learning algorithms.

• Careful planning and attention to detail are necessary to get a high quality PCCP authorized that can save time and resources for the business and speed up the innovation to better serve patients.

• Risk management professionals play a critical role in analyzing potential benefits and risks associated with PCCPs.

• Including PCCP as part of the design and development process and considering business and efficiency considerations are important.

• Gaining cross-functional experience and understanding how devices are used in clinical or home environments can help advance careers in the industry.

Keywords

PCCP, Predetermined Change Control Plan, FDA, post-market changes, software as a medical device, AI/ML-based medical devices, speed to market,

About Yu Zhao

Yu Zhao is currently the Founder and President at Bridging Consulting, LLC, a boutique Regulatory, Quality and Clinical consulting firm dedicated to providing strategic and operational consulting services to AI startups and medical device companies. He has over 20 years of industry experience, most notably at Medtronic, where he led a team of 70+ regulatory professionals supporting a multi-billion dollar business. In his current role, he is committed to enabling his clients bring safe, effective, and innovative products to the market by bridging the gap between cutting-edge technology and regulatory compliance. He holds a B.S. degree in Electrical Engineering, an M.S. in Information Management and an MBA.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.