Critical task

Human factors validation testing in the US focuses on critical tasks. Identifying them comes from the use-related risk analysis, so a weak analysis leads to tests that miss the tasks that matter.

A user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.

FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 2026), Section 3, Definitions