On August 3, 2026, FDA revised Applying Human Factors and Usability Engineering to Medical Devices, the foundational guidance that has shaped medical device human factors programs since it was first finalized in February 2016.
This is not a wholesale rewrite of FDA’s human factors expectations. The central framework remains intact: manufacturers should identify use-related hazards, evaluate and improve the user interface throughout development, implement appropriate risk controls, and validate that the final design supports safe and effective use.
However, the revision is more than an administrative date change. FDA’s own “Guidance History” table identifies three specific updates:
- Updated definitions.
- Revised Section 9, “Documentation,” for consistency with FDA’s May 2026 guidance on the content of human factors information in marketing submissions.
- Deleted Appendix A, which contained the recommended HFE/UE report structure.
Here is what you should know:
A brief summary of the revised FDA human factors guidance
The revised guidance continues to describe how human factors engineering and usability engineering should be integrated into medical device development and risk management.
FDA remains principally concerned with whether the device user interface supports safe and effective use by the intended users, for the intended uses, and in the intended use environments. The overall human factors process is therefore largely unchanged. The August revision primarily modernizes terminology and clarifies how the development-focused guidance relates to FDA’s newer submission-content framework.
How the August 2026 revision differs from the original 2016 guidance
FDA updated and expanded the definitions
One of the most visible changes is the revision of Section 3, “Definitions.” The revised guidance expands and updates that collection, drawing more directly from current versions of ANSI/AAMI/IEC 62366-1, ANSI/AAMI/ISO 14971, and applicable FDA regulations.
Newly included definitions address:
- Harm
- Normal use
- Residual risk
- Serious harm
- Serious injury
- Use environment
- Use-related risk analysis, or URRA
The revised guidance also updates several existing definitions. For example, “abnormal use” was focused on intentional, violative, reckless, or sabotaging behavior beyond reasonable risk mitigation through user-interface design. The revised definition describes abnormal use as a conscious, deliberate act or omission that violates normal use and is beyond any further reasonable means of user-interface-related risk control by the manufacturer.
The definition of “formative evaluation” is now shorter and more closely aligned with IEC 62366-1. FDA describes it as an evaluation intended to explore user-interface strengths, weaknesses, and unanticipated use errors.
“Human factors engineering” is also expressed in more standards-aligned language. The revised definition focuses on applying knowledge of human behavior, abilities, limitations, and other characteristics to the design of medical devices, systems, and tasks to achieve adequate usability.
The revised definition of “task” is broader as well. Rather than defining a task simply as an action or set of actions performed to achieve a goal, the new guidance defines it as one or more user interactions with a medical device to achieve a desired result.
Similarly, “user interface” is now presented as the means by which the user and device interact, with examples including packaging, labeling, training materials, controls, displays, alarms, and device logic.
For most manufacturers, these changes should not alter the fundamental human factors process. They do, however, improve alignment between FDA terminology, international usability-engineering standards, and the terminology used in the May 2026 submission guidance.
Section 9 now points manufacturers to the new submission guidance
The original 2016 version combined two related but distinct topics:
- Documenting the human factors process within the manufacturer’s design records.
- Determining what human factors information should be submitted to FDA. It directed manufacturers to Appendix A for a recommended eight-section HFE/UE report outline.
The revised Section 9 is much shorter. It states that documenting risk management, HFE/UE testing, and design optimization documents (like a design and development file) provide evidence that the manufacturer considered intended-user needs and determined that the device is reasonably safe and effective.
For recommendations about what documentation to include in a marketing submission, the revised guidance now directs readers to Content of Human Factors Information in Medical Device Marketing Submissions. The May 2026 guidance is now the primary source for determining what portions of that work FDA expects to receive in a particular marketing submission.
FDA deleted the former HFE/UE report appendix
The original Appendix A contained FDA’s familiar eight-section HFE/UE report outline. If you’re reading this article, you probably consulted Appendix A countless times. FDA deleted it from the revised guidance.
This does not mean FDA no longer expects a structured HFE/UE report. Instead, the recommended structure has effectively moved into the May 2026 submission guidance.
Modernized regulatory references
Another update is the modernization of regulatory terminology.
When FDA published the orginal guidance in 2016, they operated under the Quality System Regulation (QSR), and the guidance referred to concepts such as the Design History File and the former design controls regulation.
Since then, FDA has implemented the Quality Management System Regulation (QMSR), harmonizing U.S. quality system requirements with ISO 13485:2016. The revised guidance updates its language accordingly. For example, Section 9 now refers to documenting human factors activities within the manufacturer’s “design and development file” rather than relying on terminology associated with the former QSR framework.
This is primarily a terminology update and brings the guidance into alignment with today’s quality management regulations.
What should medical device manufacturers do now?
For most manufacturers, the August 2026 revision does not require rebuilding the underlying human factors process. Existing programs based on the 2016 guidance should remain broadly applicable.
However, companies should consider updating:
- Human factors procedures to reflect the revised definitions.
- URRA templates to use terminology consistent with the 2026 guidances and current standards.
- HFE/UE report templates so they align with the applicable Human Factors Submission Category (if not already done).
- Design-control references to reflect FDA’s Quality Management System Regulation and the design and development file terminology.
Research Collective’s perspective
We should view the August 2026 revision as an update rather than a rewrite.
FDA has refreshed the guidance to reflect today’s terminology, regulatory framework, and documentation practices while preserving the risk-based human factors engineering process that manufacturers have relied on since 2016.
For medical device companies, that’s good news. Existing human factors programs should require few, if any, substantive changes. The biggest takeaway is simply to ensure your procedures, templates, and documentation use current terminology and no longer reference guidance sections or appendices that have been retired. You can also safely reference the May 2026 submission guidance as the only HFE/UE document resource posited by FDA.
