Final human factors submissions guidance offers revamped documentation system

By Laura DiAngelo, MPH

The FDA has finalized long-awaited guidance on human factors information in medical device submissions, establishing a revised framework for determining the type and level of human factors documentation expected in premarket applications.

The guidance introduces a refined decision-making process for assigning submissions to one of three human factors categories, adds new considerations around user interface complexity and use-related risk analysis, and expands expectations for supporting documentation. The changes are expected to influence how device developers prepare submissions beginning later this year.

This AgencyIQ analysis examines the guidance’s key revisions, implementation timeline and potential implications for medical device sponsors.

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