Human factors validation testing

The test uses representative users, critical tasks and realistic use conditions, and it also checks that risk controls work. It is part of design validation and is done on the final design.

Testing conducted at the end of the device development process to assess user interactions with a device user interface to identify use errors that would or could result in serious harm to the patient or user. Human factors validation testing is also used to assess the effectiveness of risk control measures. Human factors validation testing represents one portion of design validation.

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