FDA AI Guidance and COA Validation: What Sponsors Need to Know

Marcela Roy, MA | Bill Byrom, PhD | Helen Brooker, PhD

The bottom line: If you're using AI in your COA program, the FDA now has a framework for how it gets validated. Here's what that means for your team.

The FDA's first guidance on using AI to support regulatory decision-making changes the rules for any sponsor using AI in clinical outcomes assessment. If your program relies on AI for missing data imputation, endpoint adjudication, or sensor-based measure derivation, you now have a formal validation framework to meet.

Signant Health's scientific and regulatory experts explain what the guidance means in practice for COA methodology, including:

• How the FDA's two-dimensional risk framework applies to eCOA use cases
• Which AI applications fall inside vs. outside the scope of the guidance
• What "black box" AI means for your regulatory submissions
• How to build a credibility assessment strategy proportionate to your program's risk level
• What early FDA engagement looks like when AI influences your decision-making

Have questions about how this framework applies to your program? Talk to our COA experts