Key Updates in the Final FDA Guidance: Content of Human Factors Information in Medical Device Marketing Submissions (2026)

By Allison Strochlic 

In May 2026, the FDA finalized its guidance, Content of Human Factors Information in Medical Device Marketing Submissions, which was previously released in December 2022 in draft form. While the foundational framework remains intact, the final guidance introduces several important refinements that substantially impact how manufacturers plan, justify and submit human factors (HF) information in premarket submissions for medical devices. 

Notably, this final guidance is intended to be a companion to – not a replacement of – the 2016 final guidance titled Applying Human Factors and Usability Engineering to Medical Devices, which outlines the process of applying HF to medical device development and details FDA’s expectations for key HF activities, methodological considerations and end-products.  

Below, we highlight five of the many key updates from the new final guidance and what they mean for medical device manufacturers preparing HF content for their FDA submissions. 

Expanded, risk-based decision-making criteria 

The final guidance further refines the decision-making framework used to determine what level of HF information is required for a submission, presented as Figure 1 of the guidance. Specifically, the flowchart in the final guidance introduces a new decision point, “D,” which reflects additional considerations beyond whether a device has new or impacted critical tasks. Specifically, “D” calls upon manufacturers to reflect on user interface (UI) use history, familiarity and complexity, as well as the adequacy of existing risk mitigations. As a result, not all devices with new or impacted critical tasks automatically require additional HF validation testing, thereby opening the door for more tailored justification strategies. 

Increased opportunities for justifying forgoing HF validation testing 

Expanding upon the prior point, the final guidance clarifies that manufacturers may, in some cases, provide a robust justification in lieu of new validation data, even if there are new or impacted critical tasks. This flexibility is especially valuable for modifications to existing devices or for devices with well-understood UIs and strong histories of safe use. While our team has successfully taken this justification pathway many times, the guidance formalizes the FDA’s acceptance of this approach, which reduces the extent of HF validation testing needed if there is a robust justification supported by a comprehensive use-related risk analysis (URRA) and other objective evidence. 

Explicit invitation to leverage existing data 

The final guidance provides clearer direction on the use of existing HF data, explicitly encouraging manufacturers to leverage prior submission content, available HF information about similar devices and existing HF validation results, rather than duplicating work unnecessarily. Furthermore, the FDA indicates that previously submitted HF content does not need to be resubmitted; instead, manufacturers may reference earlier submissions where appropriate and as shown in the examples provided in the guidance. This reflects a more pragmatic and efficient approach to regulatory submission and review and helps reduce the potential for inconsistencies in multi-part submissions. This welcome change underscores the importance of maintaining well-organized, traceable HF documentation throughout development to facilitate effective reuse and cross-referencing to streamline submissions. Of course, it is critical to have an HF expert knowledgeable about prior work and available data “at the table” when determining if and how to leverage such data, ensuring a sound approach and subsequent justification. 

Confirmed, revised HFE/UE report outline 

Previewed in and maintained from the 2022 draft, the final guidance solidifies a slightly reorganized HFE/UE report outline as compared to the final 2016 HFE guidance. Specifically, the outline switches the order of Sections 5 and 6, leading to the summary of preliminary evaluations to be followed by two consecutive sections related to the URRA and critical task identification (rather than the preliminary evaluation section separating the two risk-related sections). This outline is more conducive to telling a coherent, compelling story about the use-related risk management approach and risk profile for a given product, which is crucial for the FDA to judge the scope of HF work conducted en route to demonstrating a device’s use safety. We look forward to pivoting immediately to this reorganized flow, now that the FDA has made it official! 

Expanded set of practical examples, including detailed report outlines 

Finally, the 2026 guidance includes many more practical examples, including sample report content and outlines for each of the three HF submission categories. We were pleased to note that the examples consume three times the page count within the final guidance, as compared to the draft. These templates provide concrete examples of what the FDA expects and will likely help manufacturers include the appropriate information required in their premarket submissions. 

Notably, the expanded set of examples cover more complex and realistic scenarios, such as special user populations (e.g., pediatric users), novel interfaces (e.g., augmented reality) and devices for which there is a history of known use-related problems. These examples better reflect the broad range of devices in development and help manufacturers understand how to apply the framework to a given development effort. 

Conclusion 

The evolution of the 2022 draft version to the 2026 final guidance reflects what we have seen in practice over the past several years: the FDA’s increasing flexibility in how to demonstrate that a product can be used safely and effectively; and a continued focus on a robust use-related risk analysis and mitigation strategies as fundamental in scaling and applying HF within medical device development.  

HF submissions are no longer purely about demonstrating that testing was conducted. Rather, they are about justifying, based on risk, what level of evidence is appropriate, ensuring strong traceability between the URRA and design decisions and leveraging existing data in a thoughtful manner.  

We look forward to working the “HF Submission Category #” explanation into our future justifications and continue helping manufacturers apply HF in the most appropriate, effective way to demonstrate their medical device’s use-safety, usability, and compliance with the US FDA and other regulators’ expectations. 

Allison Strochlic is a Senior Research Director at Emergo by UL.