FDA official announcements and publications

FDA Releases Draft Guidance on AI in Medical Devices and Drug Development, Authorizing Nearly 1,000 AI-Enabled Devices as of January 15, 2025

Jan 15, 2025, 10:30 PM

The U.S. Food and Drug Administration (FDA) has released draft guidance documents aimed at regulating artificial intelligence (AI) and machine learning (ML) in the medical sector. These guidelines address the integration of AI into healthcare and biomedicine, highlighting the need for adaptive regulatory frameworks as nearly 1,000 AI-enabled medical devices have already been authorized. The draft guidance covers AI applications in medical devices, drug development, and biological products, providing crucial information for manufacturers and sponsors in the pharmaceutical industry. This initiative is expected to transform drug creation and approval processes.