FDA Issues Final Guidance for Content of Human Factors Information in Medical Device Submissions

On May 29, 2026, FDA issued a final guidance, Content of Human Factors Information in Medical Device Marketing Submissions (Final Guidance), replacing the draft version issued in December 2022 (Draft Guidance).  FDA has requested human factors (HF) information in some premarket submissions for years, but it has not always been clear, especially for 510(k)s, which device types would require HF testing as part of the submission.

At first blush, the guidance has expanded significantly in size.  However, much of the expansion is the result of several appendices providing example reports and outlines.  There is, however, one notable substantive revision: in the flowchart provided to help determine the correct HF Submission Category, FDA added Decision Point D, which sets forth considerations to undertake in determining whether HF validation testing should be included in the submission.

As in the Draft Guidance, the Final Guidance provides a flowchart illustrating a risk-based approach to determine the HF Submission Category.  Also consistent with the draft are three HF Submission Categories with increasing levels of information recommended in a marketing application:

• HF Submission Category 1 submissions (applicable to modified devices only) should provide a conclusion and high-level summary of the HF evaluation,
• HF Submission Category 2 submissions should provide a rationale for why there are no critical tasks (new devices) or no new critical tasks and/or no changes that impact critical tasks (for modified devices),
• HF Submission Category 3 submissions should provide an HF Engineering/Usability Engineering report that includes HF validation testing.

As we noted in our previous post, the Draft Guidance appeared to expand the number of submissions for which HF data would be required.  FDA addresses this concern in the Final Guidance with the addition of a fourth decision point within the flowchart.

In both the Draft and Final Guidance:

• Decision Point A asks whether the submission is for a modification to an existing device,
• Decision Point B (answered when the submission is for a modification) asks if the change is to the user interface, intended device users, intended device uses, intended use environment(s), training, or labeling,
• Decision Point C identifies if, based on a Use-Related Risk Analysis (URRA), there are critical tasks (for new devices) or new or impacted critical tasks (for modified devices).

While in the Draft Guidance, a “Yes” response to Decision Point C led to an HF Submission Category 3, the Final Guidance adds another Decision Point (D) that evaluates whether HF validation test data should be submitted based on considerations related to the:

• User interface history of use for the intended use, users, and environment(s),
• User interface complexity,
• Adequacy of existing risk control measures.

The Final Guidance notes that Decision Point D is intended to “help submitters determine whether data from human factors validation testing should be submitted in a marketing submission.”  Final Guidance at 9.  This statement is footnoted with reference to the Quality Management System Regulation (QMSR), its requirements to verify and validate the device design, and a recommendation that “human factors information be maintained by the manufacturer regardless of whether it is submitted to FDA.”  Id. at 9 n.28.  So, while Decision Point D may ease the burden of providing HF testing in some premarket submissions, FDA seems to open the door for a closer look at HF information during QMSR inspections.

The Final Guidance describes a complex user interface to include “devices that involve management such as programming, monitoring, and/or maintenance, systems with many steps such as connections, disconnections, and/or selections that influence how the device operates.”  Id. at 10.  With a risk-based approach comes some subjectivity, and there may be different opinions between FDA and industry, especially with three points being considered.  For example, will every device with a complex user interface be required to provide data from an HF validation test, or could the history of safe use of similarly complex user interfaces for the same intended use, users, and environments provide a sufficient justification that an HF validation study is not necessary?

The appendices include useful examples of justifications to support the HF Submission Category selected.  If sponsors are not clear on the appropriate HF Submission Category, or whether HF validation testing will be expected in a marketing application, the Final Guidance recommends use of the pre-submission program.  In our experience, CDRH teams expect to review the results of HF studies, and even if a company believes that, pursuant to the new guidance, the results do not need to be submitted, it should be prepared to share those results with FDA during the course of review, likely in response to a request for additional information.

With the finalization of the guidance, FDA has also updated the eSTAR templates to allow the selection of the HF Submission Category and provide the supporting information.  This now makes HF a focus of every review and, even with the risk-based approach, may result in more devices being required to conduct an HF validation study.  FDA will hold a Town Hall discussion on July 22, 2026 to discuss the Final Guidance.