FDA Guidance Overview: Human Factors Expectations for AI-Enabled Products

The U.S. Food and Drug Administration (FDA) released its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations in January 2025. This guidance includes extensive human factors (HF) expectations that directly influence AI-enabled product development.

In this 45–50-minute webinar, followed by a 10–15-minute Q&A, Emergo by UL’s human factors experts Erin Davis and Julee Henry will walk through the HF-related insights from the FDA. They’ll explain how AI-specific risks impact use-related risk analysis, what UI design principles the FDA expects, how HF validation may need to be adjusted, and what additional documentation will support an AI-enabled FDA submission.
This session is essential for teams developing AI-driven medical technologies or preparing regulatory submissions that include AI functionality.

Speakers

Erin Davis, Research Director, Human Factors Research & Design

Erin Davis is a Research Director with Emergo by UL’s Human Factors Research & Design (HFR&D) team. She has been with the team since 2012. Erin helps our clients learn about and apply human factors engineering (HFE) effectively by managing OPUS, our HFE digital platform, and by teaching workshops on various HFE topics. She has experience delivering HFE services to the medical device, pharmaceutical and in vitro diagnostic industries. A board-certified human factors professional, Erin advises on regulatory expectations, leads and oversees research activities such as user research and usability testing, and performs key HFE analysis tasks, including use-related risk analysis, known problems analysis, and residual risk analysis. Erin is co-author of two books: Medical Device Use Error – Root Cause Analysis and User Interface Requirements for Medical Devices. She has served as President of the Human Factors and Ergonomics Society’s New England Chapter and as the Medical and Drug Delivery Device Track Chair for the Healthcare Symposium. She holds a B.S. in Biomedical Engineering from Marquette University and an M.S. in Human Factors from Tufts University.

Julee Henry, Lead Human Factors Specialist

Julee Henry is a lead human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Raleigh, North Carolina. She has been with the team since 2022 and has 12 years of experience leading HFE activities, user interface design, conducting user research, and leading multidisciplinary user experience teams in the U.S. and in China. Julee advises clients on global regulatory strategies, conducts user research and usability testing, and develops key human factors analyses and documentation for regulatory submission. She holds an M.S. in Human Factors Engineering from Virginia Tech.