FDA Publishes Artificial Intelligence Paper

March 20, 2024

US Regulations


FDA has published a new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines specific focus areas regarding the development and use of AI across the medical product lifecycle.

The multi-center effort from FDA’s Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and the Office of Combination Products supports approaches to the safe, secure, ethical, and trustworthy development and use of AI.

The paper reflects the agency’s commitment to prioritize collaboration, consistency, and mutual learning in this space. It also aims to promote responsible innovation, health equity, and patient-centricity by facilitating the secure, safe, ethical, and effective deployment and use of AI in medical products and in their development.

The paper will help further align and streamline the agency’s work in AI. Read more about the agency’s AI initiatives on their website.