By Lisa M. Baumhardt, Senior Director, Regulatory Affairs CovarsaDx
September 2026
Human factors engineering (HFE) and usability engineering (UE) have long been central to the safe design of medical devices. Now, the U.S. Food and Drug Administration (FDA) has updated one of its foundational guidance documents in this area. On August 3, 2026, FDA revised its long standing 2016 guidance, Applying Human Factors and Usability Engineering to Medical Devices (“HFE guidance”)
What Has Changed in the 2026 Revision?
FDA’s HFE guidance is intended to help manufacturers apply human factors and usability engineering processes throughout medical device development so that users can operate the device safely and effectively while minimizing user errors that could cause harm. The revised HFE guidance does not abandon the fundamental HFE/UE framework established in 2016. Instead, FDA has updated and clarified the guidance to reflect the current regulatory environment and provide greater alignment with modern quality and risk-management expectations.
One of the most visible changes is the guidance’s alignment with the QMSR, which became effective on February 2, 2026. FDA explains that the QMSR incorporates ISO 13485:2016 by reference into 21 CFR Part 820. The revised HFE guidance clarifies that HFE is not an isolated regulatory activity but integrated part of the quality management activities.
The revised guidance also explicitly points manufacturers to FDA’s recently finalized Content of Human Factors Information in Medical Device Marketing Submissions (“HF content guidance”) which replaced the draft guidance from 2022. The HF content guidance assists Sponsors in determining what HFE/UE information should be included in a 510(k), De Novo, PMA or HDE submission.
This distinction is important:
The HFE guidance explains how to conduct human factors activities during device development; the HF content guidance helps manufacturers determine what human factors information should be presented in a marketing submission.
However, it should be noted that less information submitted to FDA does not mean less HFE work needs to be performed or maintained.
New eSTAR Templates
Consistent with the changes to FDA’s human factors guidance documents, referenced above, the non-IVD and IVD eSTAR templates were updated in August to include a specific section for Human Factors and Usability documentation. Sponsors are now required to input an HF Submission Category.
- HF Submission Category 1
- HF Submission Category 2
- HF Submission Category 3
If the Sponsor is uncertain about the categorization, they can choose “Guide Me” and based on interactive responses to questions within the template, it will identify the appropriate HF Submission Category. Sponsors are now required to identify where the recommended HF information resides within eSTAR (e.g., Indications for Use Statement, Device Description, Labeling, Clinical section, etc.).
Big Picture
The 2026 changes are best understood as an integrated regulatory framework rather than three unrelated updates. The revised HFE guidance establishes the development framework. The HF content guidance establishes a risk-based approach to determining what information should be included in a premarket submission. And eSTAR provides an electronic submission structure through which that information is communicated to FDA.
Next Steps
For medical device manufacturers, now is an appropriate time to review HFE procedures, documentation practices, change assessments and submission workflows. Device manufacturers should confirm that internal procedures and terminology are consistent with revised HFE guidance. Regulatory teams should incorporate the new Human Factors Submission Categories into regulatory planning. Development teams should become familiar with the updated human factors-related questions and information requested in eSTAR.
Conclusion
The organizations best positioned to navigate the new framework will be those that can demonstrate a clear, evidence-based connection between how the device was designed, how users interact with it, how use-related risks were controlled, and why the human factors information provided to FDA is appropriate for the specific submission.
CovarsaDx helps manufacturers navigate these evolving regulatory expectations by providing experienced regulatory, quality and clinical expertise specifically focused on IVDs and medical devices. Our team works with sponsors from early development through FDA submission to build regulatory strategies that align with FDA expectations.
Contact us today : Studies@CovarsaDx.com