Today, the U.S. Food and Drug Administration (FDA) issued a final guidance titled Content of Human Factors Information in Medical Device Marketing Submissions. The guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors (HF) information that should be documented and included in medical device marketing submissions to the Center for Devices and Radiological Health, including premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs), and humanitarian device exemption (HDE) applications.

This guidance is designed to streamline and, where appropriate based on risk, minimize the amount of HF information manufacturers need to provide in medical device marketing submissions, saving industry time and resources while reducing unnecessary burden. By clearly defining expectations upfront, the guidance is intended to enhance predictability of the review process and support more efficient review, with FDA resources focused on submissions with the highest usability risks.

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