The Future of AI in Regulatory Determinations

FDA's Vision for Responsible Use of Artificial Intelligence for Drug and Biologic Regulatory Determinations

Artificial Intelligence (AI) is transforming the way regulatory decisions are made. As of January 6, 2025, FDA released a guidance document outlining how AI should be used to produce information or data intended to support regulatory decision-making. The guidance includes a risk-based credibility assessment framework for establishing and evaluating AI models. The assessment focuses on the model’s particular context of use (COU). AI is already playing a role in drug discovery, clinical trials, and manufacturing. The complexity of these AI models has led FDA to ensure models are credible, reliable and transparent before being used to support regulatory decisions. Although the target industry for this guidance is aimed at drug and biologic products, the agency signaled its application to medical devices with the involvement of the Center for Devices and Radiological Health (CDRH) in the development of the guidance document.