FDA Human Factors Guidance for Medical Devices: What Changed in 2026 and why it matters

The FDA made three important changes to their human factors guidance for medical devices in 2026 that significantly impact how medical device teams plan, document, and submit human factors work.

Takeaways

The most consequential was the May publication of Content of Human Factors Information in Medical Device Marketing Submissions. This final guidance, based on the 2022 draft version, provides a risk-based framework for determining how much human factors information the FDA recommends including in a marketing submission. Tthe FDA also revised its core guidance Applying Human Factors and Usability Engineering to Medical Devices in August 2026 to align definitions and documentation with the new submission content guidance. Finally, in 2026, the Quality Management System Regulation (QMSR) took effect, changing the regulatory context and some documentation terminology.

These changes are critical for medical device manufacturers, the biggest one being a new Decision Point D in the submission flowchart. Under the 2022 draft, identifying any critical tasks (Decision Point C) automatically pushed a manufacturer into a Category 3 submission which then required full human factors validation testing. This 2026 final guidance adds a further step: even with new or impacted critical tasks, the manufacturer must evaluate the user interface's history of use, its familiarity and complexity, and the adequacy of existing risk controls before concluding validation data must be submitted. In practice that means manufacturers must now provide a robust justification in lieu of new validation data (this is especially true for device modifications or interfaces with an established track record) which formalizes something the FDA previously only accepted informally.

On a positive note, the guidance keeps the three risk-based submission categories (Category 1: high-level HF summary for modified devices; Category 2: rationale for no critical tasks or none impacted; Category 3: full HFE/UE report with validation), but now makes it easier to land in a lower category with good argumentation. The new guidance also explicitly encourages leveraging existing data but does reorganize the structure where in a HFE/UE report preliminary evaluations precede the use-related risk analysis and critical task sections. The new guidance also roughly triples the number of worked examples, covering special populations, novel interfaces, and devices with known use-safety issues.

Ultimately, with these changes the submission burden is decreased for well-understood interfaces. However, the analytical burden shifts to the use-related risk analysis and the quality of the manufacturer’s justification. The inspection stakes also go up since the FDA expects the complete human factors file to exist under the QMSR whether or not it's submitted. For a manufacturer, that means the URRA and critical-task rationale become the load-bearing documents, and weak justifications are the likeliest new source of deficiency letters.

The new submission guidance was created to complement the FDA’s core human factors guidance

The May 2026 Content of Human Factors Information in Medical Device Marketing Submissions finalizes the three Human Factors Submission Categories first introduced in the 2022 draft. The categories provide a decision framework to help companies determine the amount of human factors documentation required for a medical device marketing submission. Importantly, this guidance focuses on marketing submission content and is not intended to guide or prescribe how manufacturers perform human factors evaluations during device development.

“Submission category governs submission content. It does not define the HFE/UE activities a manufacturer should perform during development. FDA recommends maintaining human-factors information regardless of whether it is submitted, and applicable QMSR record requirements still apply.”

A Category 1 or 2 submission may still rely on substantial use-related risk analysis, formative evaluation, and other essential human factors analysis work.

The Three HF Submission Categories

The decision framework determining the submission category starts with whether the submission concerns a new device or a modification to an existing device. For a modified device, the framework asks whether the change affects the human-factors assessment. It then considers critical tasks and whether human-factors validation data should be submitted. 

Implementing a URRA is critical for determining submission category

The use-related risk analysis, or URRA, is a pivotal human factors process that connects user tasks and possible use errors to hazards, potential harm, severity, critical task status, risk controls, and evidence that those controls are effective. The traceability provided by the URRA informs the design and is an important driver behind the information included in the submission.

For a modified device, the FDA recommends assessing the final finished device rather than limiting the analysis to just the changed component(s); a modification can affect upstream or downstream critical tasks, and multiple small changes can have a cumulative effect. The assessment follows how the user will perceive, understand, and physically interact with the finished device, including consequences that may not be obvious when only looking at changed components.

When categorization is uncertain, the content guidance recommends seeking feedback through a Pre-Submission. FDA's core HFE/UE guidance also encourages manufacturers to submit a draft validation protocol before conducting the test. For a new interface, an affected critical task, or a borderline rationale in lieu of validation data, that feedback can be more useful before a protocol and recruiting plan are finalized.

The FDA also updated the core human factors engineering guidance

In August 2026 the FDA released revisions to their guidance Applying Human Factors and Usability Engineering to Medical Devices. The updates included three main changes:

1. Definitions were updated to align more closely with current human factors and risk management terminology. Notable additions include URRA, normal use, residual risk, serious harm, and use environment, with references to current editions of IEC 62366-1 and ISO 14971 where relevant.

2. Section 9, “Documentation,” has been revised. The previous version included guidance for both documenting human factors processes within a manufacturers internal records as well as guidance for what should be included in a submission. The updated version of Section 9 is shorter, directing readers to the new May submission content guidance. 

3. The previous Appendix A HFE/UE report outline was removed. Category-specific report recommendations now live in the new May submission guidance document.

Quality Management System Regulation (QMSR) changes also took effect in 2026

The new Quality Management System Regulation (QMSR) took effect in February 2026 and changed some of the regulatory structure and terminology surrounding device design and development. The  new QMSR incorporates ISO 13485:2016, modernizing U.S. device regulations to align with international standards.

Key Takeaways for Medical Device Teams

The FDA published the submission content guidance on May 29, 2026 and provided an implementation period through July. Submissions received before August 1 generally were not expected to include the newly recommended information or use the updated Electronic Submission Template and Resource (eSTAR), although the FDA stated it would be reviewed if provided.

The new submission categories may change what a team sends to FDA, but the core development questions and human factors engineering processes remain substantially the same:

• Who will use the device, for what purpose, in which environments, and with what training?

• Where can interactions with the device contribute to use error or harm?

• Which tasks are critical because incorrect performance or omission could cause serious harm, including compromised medical care?

• What can analytical and formative work reveal while the interface can still change?

• Have risk controls been implemented in the preferred order: inherent safety by design, protective measures, then information for safety?

• When validation is appropriate, does testing of the final interface represent intended users, critical tasks, and realistic use conditions?

Moving forward, device teams should ensure that their internal processes and documentation align with the new guidance.

• Use the final device and a current URRA to determine the category and document the rationale. For modified devices, include cumulative and downstream effects in the assessment.

• Ensure URRA and report templates are updated to use the latest definitions

• Ensure report templates use the new category structure provided in the May submission guidance

• Update any internal procedures and processes to align with new terminology and definitions

HF Designworks supports medical device teams with human factors engineering, user research, use-related risk analysis, formative evaluations, usability evaluations, and product design guidance. Contact us to learn more and to discuss a human factors engineering engagement with your medical device team.

This article provides general educational information and is not legal or regulatory advice.