Content of Human Factors Information in Medical Device Marketing Submissions Guidance for Industry and Food and Drug Administration Staff May 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2015-D-4599
• Issued by: Center for Devices and Radiological Health

The FDA recognizes and anticipates that the Agency and industry may need a minimum of 60 days to perform activities to operationalize the policies within this guidance. For regulatory submissions that are currently pending with the FDA after publication of the guidance, as well as those submissions received before August 1, 2026, the FDA generally does not anticipate that manufacturers will be ready to include the newly recommended information outlined in the guidance in their submission. The FDA, however, intends to review any such information if submitted at any time.

This guidance document provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be documented and included in medical device marketing submissions, including premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs) and humanitarian device exemption (HDE) applications. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.

This guidance is intended to be used as a companion to the final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices.”

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