Foley & Lardner LLP attorneys Kyle Faget, Nathan Beaver, David Rosen, and Sheridan Organ authored the MD+DI article, “FDA Outlines AI Medical Device Software Recommendations in Draft Guidance.”
The authors explore key themes from the U.S. Food and Drug Administration’s January 2024 draft guidance for developers of AI-enabled medical devices, including the FDA’s emphasis on continuous post-market monitoring, transparency, and addressing AI bias throughout the device lifecycle. They also describe important considerations for device descriptions, user interface design, risk assessment, data management, validation, and cybersecurity.
