Human factors isn't a checkbox: What FDA's eSTAR requirements mean for MedTech submissions

The FDA's new 2026 eSTAR v7.0 guidance for medical device submissions shifts the focus from simply validating human factors to demonstrating that use-related risks are acceptably managed. Device risk category now defines the level of human factors evidence needed, with Category 3 devices requiring human factors validation tests due to critical tasks that could cause severe harm.

This Wire brief sits within Fusion42's coverage of Medtech.