Town Hall | Virtual
Event Title
Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance
July 22, 2026
- Date:
- July 22, 2026
- Time:
- 1:00 p.m. - 2:00 p.m. ET
Summary
The U.S. Food and Drug Administration (FDA) held a town hall for industry and other interested parties to discuss the final guidance titled Content of Human Factors Information in Medical Device Marketing Submissions, issued on May 29, 2026.
Background
An important consideration for medical devices is the critical impact the device user interface design has on the safe and effective use of the device. Manufacturers routinely perform human factors assessments of the device user interface during device development.
The purpose of this guidance is to provide a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health (CDRH) to facilitate the efficiency of the FDA review process.
This final guidance is intended to be used to complement the FDA guidance titled Applying Human Factors and Usability Engineering to Medical Devices.
Event Materials
The presentation, printable slides, and transcript are available on this webpage and at CDRH Learn under “Specialty Technical Topics,” sub-section “Human Factors.”
If you have questions about this town hall, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.