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.”