Human Factors Engineering

New FDA Requirements in eSTAR Move Usability Factors from the Testing Box to the Risk File

The FDA’s 2026 guidance, incorporated into the eSTAR v7.0 form, states that companies are required to demonstrate the acceptability of use-related risks associated with medical devices, not merely submit a human factors testing report. The level of risk and whether use tasks are critical determine the amount of evidence and documentation required in the submission file.