New FDA-Guidance for Industry on AI : Draft release

The U.S. FDA released a draft guidance in January 2025 on AI use in regulatory decision-making for drug and biological products. The guidance provides recommendations for sponsors on ensuring AI models are credible for assessing safety, efficacy, and quality.

A risk-based approach is introduced, outlining seven steps:

1. Define the question of interest.
2. Establish the AI model’s context of use (COU).
3. Assess AI model risk.
4. Develop a credibility plan for the AI model.
5. Execute the plan.
6. Document results and any deviations.
7. Determine if the model is adequate for its COU.

The FDA stresses continuous AI monitoring, ensuring models remain reliable over time. Early communication with the FDA is encouraged. Public comments on the draft can be submitted until April 7, 2025.

12-03-2025