Lexology April 10, 2024
Troutman Pepper

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 (OCP). The report reflects the FDA’s commitment to both fostering innovation in medical technology and safeguarding patient health through regulation, standard-setting, and monitoring.

The FDA identifies four priorities for the development and use of AI across the medical product life cycle:

(1) Fostering collaboration to safeguard public health;

(2)...

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Technology
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