Artificial intelligence (AI)

This is the FDA definition used in its guidance on predetermined change control plans. For a device, what matters is less whether the product is called AI and more whether it uses a model whose behavior can change with data, which affects how changes are planned and reviewed.

A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. Artificial intelligence systems use machine- and human-based inputs to perceive real and virtual environments; abstract such perceptions into models through analysis in an automated manner; and use model inference to formulate options for information or action.

FDA guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025), Section IV, Definitions