Talk
Exploring regulatory pathways for AI in clinical studies: the PCCP approach and FDA methodologies
Tue, Jun 3, 2025 · 11:00–11:30 AM CDT Minneapolis Marriott West
About this session
This session focuses on regulatory strategies that enable the continuous improvement of AI algorithms in clinical applications. We will examine the Predetermined Change Control Plan (PCCP) approach and FDA methodologies to ensure compliance while maintaining innovation.
Key Topics:
- Understanding the PCCP approach – how it facilitates AI updates while ensuring regulatory compliance
- Best practices for AI algorithm updates – methods for maintaining performance, safety, and clinical efficacy
- Case studies – real-world examples of AI regulatory approvals and iterative updates in clinical settings
