How to Measure Performance for Ai-Enabled Medical Devices? FDA Seeks Public Input

On September 30, 2025, the U.S. Food and Drug Administration (FDA) posted a Request for Public Comment regarding how to measure the performance of medical devices enabled with artificial intelligence (AI). The FDA noted that this is not a draft or final guidance, nor does it propose policy changes. The purpose is to gather early feedback from outside of the FDA….
By: Knobbe Martens