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

Human factors isn’t a checkbox: What FDA’s eSTAR requirements mean for MedTech submissions is a pharma and life sciences industry update from MedTech Dive. The story may affect commercial strategy, market access planning, stakeholder engagement, competitive positioning, and near-term monitoring for pharmaceutical and biotech teams.

Di Lu, Associate Director, Regulatory Affairs | Human Factors and Usability Engineering at IQVIA MedTech · 2026-09-14

FDA’s eSTAR framework raises the bar for documenting human factors and use-related risk.

Source: MedTech Dive