Kyle Dolinsky

Apr 12, 2024 | jdsupra.com | Kyle Dolinsky |Linnea J. Kelly |Brett Mason

On March 15, the U.S. Food and Drug Administration (FDA) published a paper titled " Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together." This paper describes the FDA's strategy for incorporating artificial intelligence (AI) into medical products within 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...