Lexology April 10, 2024
On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining how the FDA intends to approach artificial intelligence (AI) use in the medical product life cycle. The paper was issued by 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 the Office of Combination Products (OCP) (collectively, the Centers). In it, the Centers discuss plans for forthcoming FDA actions and guidance that the Centers believe balance safeguards for public health and promoting innovation.
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