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SUMMARY:Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions\, Final Guidance
DESCRIPTION: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. \nKey topics include: \n\nThe importance of evaluating user interface design during device development\nExpectations for documenting human factors and usability information in marketing submissions\nAlignment with existing guidance\, including Applying Human Factors and Usability Engineering to Medical Devices\n\nThe event is intended to provide clarity on regulatory expectations and facilitate discussion on integrating human factors considerations into medical device development and submission processes. \nVisit the event page for more information.
URL:https://about.citiprogram.org/event/town-hall-content-of-human-factors-information-in-medical-device-marketing-submissions-final-guidance/
LOCATION:Online
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