FDA publishes final guidance on human factors information in marketing submissions

The US Food and Drug Administration (FDA) has finalised its guidance titled ‘Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff,’ superseding the draft released in December 2022.

The guidance 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, the Agency explains.

“The recommendations in this guidance are intended to be generally applicable for all medical devices reviewed by CDRH,” the Agency added, although “if there are device-specific guidances or requirements, the applicable recommendations should, and applicable requirements must, be followed.”

Under the section on how to determine the human factors submission category, FDA has added a new decision point on whether human factors validation test data should be submitted when considering the interface history of the intended use and its environment, device user interface complexity, and the adequacy of existing risk control measures. The agency said sponsors should assess the use-related risk analysis (URRA) when considering the decision point.

“For modified devices where critical tasks are impacted by the modification but existing risk control measures remain effective at eliminating or reducing the risk, submitters can consider providing a rationale in lieu of submitting new human factors validation testing,” the guidance adds. “Such rationale should include objective evidence that the risk controls remain effective.”

The Agency clarified that the new guidance should be considered alongside the other current usability-related guidance ‘Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff,’ published in February 2016.