How to get AI/ML SaMD FDA cleared - Presentation by: Yujan Shrestha

The discussion focused on key takeaways from the Arsene conference, balancing safety with market speed, and determining risk analysis thresholds. Topics included statistical power vs. generalizability, U.S. data requirements, and AI/ML sample size considerations. The PCCP tool was highlighted as a strategy to de-risk regulatory pathways and accelerate pre-market submissions. Participants emphasized collaboration between regulatory and engineering teams to navigate software modifications effectively.
Participants
Yujan Shrestha - CEO Innolitics
George Hattub - Senior Regulatory Affairs Project Manager
Richie Christian
Joshua Tzucker - Seniour Software Engineer
Key Takeaways
1. Companies must balance delivering safe and effective products with timely market entry, which can be challenging during development.
2. Statistical Power vs. Generalizability: Statistical analysis ensures validity but does not guarantee a device’s generalizability to the U.S. population, emphasizing the need for diverse and representative data.
3. Risk Analysis Threshold: Knowing when to stop risk analysis is critical-teams should aim for a product they would trust for themselves or their families.
4. PCCP for Regulatory Flexibility: The Predetermined Change Control Plan (PCCP) provides a proactive strategy to manage AI/ML changes, reduce regulatory uncertainty, and speed up pre-market submissions.
5. U.S. Population Data Requirements: The FDA emphasizes that over 50% of clinical data must come from the U.S. to ensure devices align with local practices and demographics.
Timestamps
00:25 Discussion Setup and Participants
00:57 Personal Note - Work-Life Balance
02:26 Balancing Safety and Market Speed
03:55 Knowing When to Stop Risk Analysis
04:32 Statistical Power vs. Generalizability
06:52 Sample Size Determination for AI/ML
10:22 U.S. Population Data Requirements
14:40 Multi-Reader Studies and FDA Guidelines
18:53 Handling Software Modifications and Regulatory Pathways
27:54 FDA Challenges and Regulatory Evolution
34:35 PCCP as a Strategy for Pre-Market Submission
41:12 PCCP Limitations and Commercial Considerations
44:03 PCCP Practical Implementation and Q&A
46:50 Conclusion and Closing Remarks
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