FDA Human Factors Guidance 2026: Navigating New eSTAR Requirements

Medical Device Global Market Access · Aug 9, 2026 · 5m

The US FDA has finalized its guidance on 'Content of Human Factors Information in Medical Device Marketing Submissions,' introducing a new risk-based framework that became mandatory within the eSTAR portal on August 1, 2026. This episode details the three new risk categories for Human Factors Engineering (HFE) and Usability Engineering (UE) data, explains how they impact 510(k), PMA, and De Novo submissions, and provides practical steps for manufacturers to adapt their processes and documentation to meet these updated requirements. Key Questions: - What is the FDA's finalized guidance on…