The US Food and Drug Administration (FDA) is seeking public input on its draft guidance for artificial intelligence (AI)-enabled medical devices. The agency is specifically looking for comments on how well the guidance aligns with the AI lifecycle, as well as its adequacy in addressing concerns related to emerging technologies such as generative AI. Additionally, the FDA wants feedback on its approach to monitoring device performance and communicating information about AI-enabled devices to users. A webinar will be held on February 18, 2025, to discuss the draft guidance further.
https://www.prnewswire.com/news-releases/fda-issues-comprehensive-draft-guidance-for-developers-of-artificial-intelligence-enabled-medical-devices-302343044.html