FDA Guidance Requires Clinical Trial Sponsors to Validate AI Algorithms

The U.S. Food and Drug Administration (FDA)'s January 2025 draft guidance on artificial intelligence (AI) in regulatory decision-making now formally requires clinical trial sponsors to validate AI algorithms. The guidance introduces a risk-based credibility framework, mandating that sponsors calibrate validation efforts based on the consequence of the AI output for regulatory decisions. Sponsors must provide audit-ready evidence demonstrating that AI tools used for tasks such as data cleaning or flagging protocol deviations produced reliable outputs for specific uses.