Comment from Aayushee Shah

I appreciate FDA’s inclusion of hypothetical examples to demonstrate how sponsors may approach defining the question of interest, the context of use (COU), and the model risk assessment. However, the explanation in lines 138–148 describing why the examples stop at step 3 is difficult to follow in its current form and may be confusing for readers who are new to the framework. I recommend that FDA revise this explanation to be more direct and accessible and consider relocating it to the end of the section, after all seven steps have been described. This would help readers understand the examples in context and reduce confusion about their intended purpose. Below is suggested alternative wording for clarity: “FDA provides two hypothetical examples to illustrate steps 1 through 3 of the 7‑step credibility assessment framework (describing the question of interest, defining the COU, and assessing model risk). These examples do not extend beyond step 3 because steps 4 through 7 involve credibility assessment activities that are highly dependent on the specifics of each AI model, dataset, and development program. Since these later steps must be tailored to individual programs, extending the examples further could lead to oversimplification or misinterpretation. Accordingly, the examples are intended only to demonstrate the foundational concepts in steps 1–3.” Providing this clearer explanation, ideally after the full overview of steps 1–7 would make the guidance more user‑friendly and support consistent interpretation by sponsors and other stakeholders.