HFE/UE Report

Purpose: evidence instead of retelling

A widespread misunderstanding is to treat the HFE/UE report as a retrospective summary of completed activities, a kind of record of what has been done anyway. Its actual purpose is a different one: It is meant to enable a reviewer at the FDA to understand without queries that the entire process was complete, methodologically appropriate and internally consistent, from the identified user groups to the justification of why remaining risks are acceptable.

This traceability is the actual yardstick of the review. A report that merely lists activities without disclosing the chain of reasoning between them, why exactly these critical tasks followed from this task analysis, why these formative findings led to those design changes, makes the review more difficult and provokes queries that delay the approval process.

Recommended structure of the report

The FDA describes the structure in the guidance “Content of Human Factors Information in Medical Device Marketing Submissions” (final since May 2026). It is a recommendation, not a mandatory template, and provides for eight sections:

1. Conclusion and summary: Statement of whether the user interface is appropriately designed for the intended users, uses and use environments, as well as the chosen human factors submission category with justification.
2. Description of the intended users, uses, use environments and training, comparable to the use specification according to IEC 62366-1.
3. Description of the user interface, including labeling.
4. Summary of known use problems from predecessor models and comparable products.
5. Summary of the preparatory analyses and formative evaluations and the design changes derived from them.
6. Analysis of the hazards and risks of use: the use-related risk analysis (URRA).
7. Identification and description of the critical tasks with the procedure by which they were derived from the use-related risk analysis.
8. Human factors validation testing of the final design: type of test, participants, training, tasks and scenarios tested, results, analysis of all use errors and problems as well as the benefit-risk consideration of the residual risks.

The report deliberately begins with the conclusion. The remaining sections follow the course of the human factors process so that a reviewer can follow the chain of reasoning step by step from the first description of users to the final result.

Scope according to human factors submission category

How much of this has to be submitted has been determined since 2026 by the human factors submission category. The FDA distinguishes three categories:

• Category 1: The conclusion and summary (section 1) are sufficient. It applies above all to modified products whose modification does not affect the human factors assessment.
• Category 2: Sections 2 to 4 and a justification of why no validation data are submitted are added. It applies if there are no critical tasks, if no critical tasks newly arise or are affected for a modified product, or if the omission of validation data can be justified.
• Category 3: The complete HFE/UE report with all eight sections, including the results of the human factors validation testing.

The manufacturer derives the classification from the use-related risk analysis. For submissions received before August 1, 2026, the FDA generally does not yet expect the newly recommended information.

The most critical section: assessment of the validation results

In experience, the section on the assessment of the validation results receives the greatest attention in the review. Here, for every observed difficulty, not only complete failures but also laborious or detour-based successful task completions, a cause must be assigned: Is it a perception, comprehension or execution problem?

It must then be justified why the remaining risk is acceptable, for example because a design change has already been made and its effectiveness tested again. If residual risks remain, the FDA expects an explanation of why further risk reduction is not possible or not practicable, supported by a benefit-risk analysis. A mere statement that a problem occurred, without this classification, is considered insufficient and in practice leads to queries from the authority.

When the report is created

A frequent but avoidable mistake is to write the report only after all activities are completed. A more sensible approach is one in which the report structure is set up at the start of the project and filled continuously with the results of each analysis phase. This enforces consistency from the beginning: Justifications that have to be constructed only retrospectively for decisions already made are noticeably weaker than those that accompany the decision process from the start.

This continuous approach also makes it easier to deal with design changes over the course of the project: Every change and its justification can be documented immediately instead of reconstructing it at the end from memory or scattered project documents.

Delimitation from the usability engineering file

The HFE/UE report is closely related in content to the usability engineering file according to IEC 62366-1 but not identical. The usability engineering file is the complete, European-influenced documentation of the entire process, whereas the HFE/UE report is the summarized presentation for the US submission, tailored to FDA expectations.

In practice, the HFE/UE report can usually be created as a focused extract from a completely maintained usability engineering file, provided it was kept consistent and comprehensible from the start. If the file was maintained with gaps, however, creating the report becomes a retrospective reconstruction, with correspondingly higher effort and a greater risk of inconsistencies.

Regulatory reference

The HFE/UE report is part of many FDA submissions (510(k), De Novo, PMA and HDE) for products with relevant use risk. The process is described by the FDA human factors guidance, the structure and scope of the report by the guidance “Content of Human Factors Information in Medical Device Marketing Submissions” of May 2026. Product-specific guidance of the authority can formulate additional expectations. Combination products are not addressed by this guidance.

In terms of content, the report corresponds in its function to the European usability engineering file according to IEC 62366-1. Both document the same underlying process for different reviewing bodies. For manufacturers seeking approval in both the EU and the US, the usability engineering file maintained according to IEC 62366-1 therefore often forms the basis both for the MDR evidence and for the later FDA report. The contents must, however, be transferred into the structure of argument expected by the FDA.

Frequently asked questions (FAQ)

Sources

• IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
• Regulation (EU) 2017/745 on medical devices (MDR)
• FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices
• FDA Guidance: Content of Human Factors Information in Medical Device Marketing Submissions

Related terms

• FDA human factors guidance
• Usability engineering file
• Summative usability evaluation
• Critical task
• Use-related risk analysis (URRA)
• IEC 62366-1
• Human factors validation testing

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