Use-related risk analysis (URRA)

The URRA identifies critical tasks and links each one to the risk controls and human factors testing that address it. FDA uses it to judge how much human factors information a submission needs.

Systematic use of available information to identify use-related hazards and to estimate the use-related risk.

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