What guidance documents on human factors (HF) has FDA released?

In May of 2026 the FDA released the guidance document, Content of Human Factors Information in Medical Device Marketing Submissions, which replaced the draft version from 2022. A companion guidance, Applying Human Factors and Usability Engineering to Medical Devices, is referred to as the Human Factors Guidance. The Human Factors Guidance, which FDA just updated on August 3, 2026, is more of a “how-to” for manufacturers during the HFE/UE process, focusing on critical tasks, use-related risk analysis, residual risk, and validation testing. The 2026 Content of Human Factors Information in Medical Device Marketing Submissions guidance is intended to complement the Human Factors guidance. Combination products are explicitly not addressed by the 2026 HF guidance, and sponsors are directed to the appropriate Center and the guidance document Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.

Differences between the 2022 and 2026 Content of Human Factors Information in Medical Device Marketing Submissions guidance documents

The draft and final versions of Content of Human Factors Information in Medical Device Marketing Submissions both aimed to provide a risk-based framework, based on HF Submission Categories, so that manufacturers would know what human factors information to include in marketing submissions.

2026 Updated Definitions

In the definitions section, the footnotes have been updated to current editions of IEC 62366-1 and ISO 14971. The definition for “use safety” has been shortened to now simply mean “freedom from unacceptable use-related risk.” “URRA” is now consistently used to mean use-related risk analysis.

2026 Updated Decision Flowchart

The decision flowchart for assigning a Human Factors (HF) Submission Category has changed from the 2022 draft to the 2026 final version, most notably adding Decision Point D which asks:

Given the following considerations, should human factors validation test data be submitted?
• User interface history of use for the intended use, users, and environment(s)
• User interface complexity
• Adequacy of existing risk control measures

This addition allows some devices which do have critical tasks to stay in HF Submission Category 2 with a well-supported rationale, instead of automatically requiring full HF validation testing data to be submitted to the FDA. The document suggests that “Submitters should assess the URRA when answering this question, and examine multiple considerations, including but not limited to intended user, uses, technological characteristics, user familiarity and experience with device user interface, user characteristics, clinical impact of use errors, and use environment.” This allows greater flexibility based on real-world factors such as established history of safe use, low complexity, or still-effective existing risk controls. The application of Decision Point D can be tricky. To assist in deciding whether a rationale can be provided (HF Submission Category 2) or if the level of information would fall into HF Submission Category 3, submitters may:

• Conduct comparative analyses to similar legally marketed devices (e.g., labeling comparison, comparative task analysis, physical comparison) for the purposes of identifying what differences exist between the device user interfaces and where the same or similar risks may apply to the subject device.
• Check Section VI of the guidance for additional examples that illustrate the decision-making on whether human factors validation testing should be submitted
• Seek feedback through a Pre-Submission if they are not sure whether a rationale would be appropriate for their specific marketing submission

2026 Other Changes

Both versions contained the FDA suggestion that, for modified devices, submitters consider the URRA on the final finished device and not just modifications to the device. However, the 2026 version specifies that there can be a cumulative effect of multiple modifications – the critical task could then be impacted by the cumulative changes (and therefore the HF Submission Category may change).

Additionally, the 2026 version provides the new and helpful tip that “Human factors validation test data are likely needed to support marketing authorization for devices with complex user interfaces (e.g., 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) and/or if the device type historically has been associated with known use error issues (e.g., infusion pumps).”

Be sure to check the appendices of the 2026 Content of Human Factors Information in Medical Device Marketing Submissions guidance for helpful sample report content for all three HF Submission Categories.