Context of Use

Context of Use (CoU) is the specific role and scope of an AI model used to address a Question of Interest – the FDA’s articulation of the Intended Use at the process level. The CoU spans forward: it defines the requirement the system has to fulfill (Credibility spans back and assesses fulfillment). Important: equating CoU and Intended Use holds only through the process anchoring. Where the CoU describes the role in the process, it is the Intended Use in FDA language; where its purpose merely defines the output of the model or AI system, you are at the tool level – Function instead of Purpose, the System/Function/Purpose error.