Artificial intelligence-enabled device software function (AI-DSF)

The term defines the scope of FDA guidance on predetermined change control plans. If a software function uses an AI model and meets the device definition, it is an AI-DSF and the guidance on planning future model changes applies to it.

A device software function (as defined above) that implements an AI model. AI-DSFs are the focus of this guidance.

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