Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance

The U.S. Food and Drug Administration (FDA) will host a town hall for industry stakeholders and other interested parties to discuss the final guidance, Content of Human Factors Information in Medical Device Marketing Submissions, issued on May 29, 2026. The session will focus on the role of human factors and user interface design in supporting the safe and effective use of medical devices, as well as the implications of the new guidance for regulatory submissions.

Key topics include:

• The importance of evaluating user interface design during device development
• Expectations for documenting human factors and usability information in marketing submissions
• Alignment with existing guidance, including Applying Human Factors and Usability Engineering to Medical Devices

The event is intended to provide clarity on regulatory expectations and facilitate discussion on integrating human factors considerations into medical device development and submission processes.

Visit the event page for more information.