FDA Guidance On Artificial Intelligence & Medical Products: How CBER, CDER, CDRH & OCP Are Working Together

On March 13, 2024, the U.S. Food & Drug Administration (FDA) published this guidance regarding how the FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) are working together on artificial intelligence (AI) and medical products. This paper describes four areas of focus for CBER, CDER, CDRH, and OCP regarding the development and use of AI across the medical product life cycle . . .