Artificial Intelligence Paper Outlines FDA’s Approach to Protect Public Health and Promote Ethical Innovation

March 15, 2024 — Today, the U.S. Food and Drug Administration (FDA) released its “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how FDA’s medical product centers are working together to protect public health while fostering responsible innovation in artificial intelligence (AI) used in medical products and their development. AI, including machine learning (ML), spans transformative technologies with the potential to revolutionize healthcare. The paper reaffirms our commitment to promote health equity by promoting the secure, safe, ethical, and effective development, deployment, and use of AI in medical products. The complex and dynamic processes involved in the development, deployment, use, and maintenance of AI technologies benefit from careful management throughout the medical product life cycle. This paper describes our shared commitment and outlines four priorities for cross-center collaboration to foster consistency across the FDA. Published by the FDA’s Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP), this paper represents our longstanding commitment to protect public health and advance innovation. The  “ Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” is meant to complement the “Artificial Intelligence and Machine Learning Software as Medical Device Action Plan,” published in January 2021. You can read the full paper here.