FDA Finalizes Human Factors Guidance for Medical Device Marketing Submissions

For medical device manufacturers, the U.S. Food and Drug Administration's (FDA) final human factors guidance offers a clearer path for deciding what human factors engineering and usability engineering (HFE/UE) information to include in marketing submissions. This can make it easier to scope documentation, anticipate testing needs, and reduce uncertainty as teams prepare 510(k)s, De Novo requests, premarket approvals (PMAs), and HDEs.

As in the draft guidance, the final guidance, "Content of Human Factors Information in Medical Device Marketing Submissions," includes a risk-based flowchart for determining the type and level of HFE/UE information appropriate to support each submission. For manufacturers, the framework provides more structure around when a brief rationale may be sufficient for a marketing submission and when more detailed validation evidence is expected. This guidance document serves as a companion to the final guidance document entitled, "Applying Human Factors and Usability Engineering to Medical Devices." 

FDA has also updated its electronic Submission Template and Resource (eSTAR) program to reflect the FDA's focus on human factors for medical device submissions. Beginning August 1, 2026, the revised non-IVD and IVD templates will prompt manufacturers to identify the appropriate Human Factors Submission Category and provide supporting information accordingly. This change may warrant early planning for manufacturers preparing future submissions and device modifications.

Key takeaways for medical device manufacturers

The guidance organizes submissions into three Human Factors Submission Categories. Category 1 generally applies to certain modified devices where manufacturers provide a high-level summary of their human factors evaluation. Category 2 applies when there are no critical tasks for a new device, or no new or impacted critical tasks for a modified device, and manufacturers provide supporting rationale. Category 3 applies when critical tasks or use-related risks warrant more comprehensive human factors documentation, including human factors validation testing and a full HFE/UE report.

In practice, that means some lower-risk modifications may be addressed with a concise rationale, while submissions involving new or affected critical tasks may call for more detailed HFE/UE documentation, including validation testing and a full report. New examples and appendices in the final guidance document add context for category selection and documentation approaches across different submission scenarios.

A new decision point (i.e., Decision Point D) in FDA's risk-based flowchart provides context on when data from human factors validation testing should be submitted. This point in the final guidance includes a footnote that regardless of whether human factors information is submitted to FDA, it should be maintained by the manufacturer, indicating that such information may be reviewed during the course of an FDA inspection. This decision point asks the manufacturer to consider aspects such as the user interface history of use for the intended use, users, and environment(s), its complexity, and the adequacy of existing risk controls.

What manufacturers can consider now

With the final guidance now reflected in eSTAR, manufacturers preparing upcoming medical device submissions may want to evaluate whether their human factors processes and documentation align with FDA's updated framework.

Areas to review can include:

• Current HFE/UE documentation considering the new FDA marketing submission categories
• URRAs that support marketing submission category determinations
• Whether device modifications affect users, use environments, training, labeling, or critical tasks
• Whether human factors validation testing may be needed under FDA's risk-based framework
• Use of FDA's Pre-Submission Program when there is uncertainty around category selection or testing expectations

Taken together, the final marketing submissions guidance and eSTAR updates offer a clearer view of FDA's expectations for human factors information in medical device submissions. As manufacturers plan future submissions and device modifications, earlier attention to use-related risks, documentation strategy, and validation needs could make the review process more efficient and help reduce uncertainty. 

Exponent can help manufacturers interpret the new guidance and assist with answering the questions presented in the risk-based flowchart. Our experience with URRAs, identification of critical tasks, and development, implementation, and reporting on human factors formative and summative protocols help companies best position themselves for IRB/site readiness and FDA submissions.