On May 29, 2026, FDA issued its final guidance, “Content of Human Factors Information in Medical Device Marketing Submissions.” The guidance provides a risk-based framework for determining what human factors information should be documented and included in medical device marketing submissions, including 510(k)s, De Novo requests, PMAs, and HDE applications.

FDA’s stated goal is to promote consistency and help facilitate more efficient review of medical device submissions.

For medical device and combination product teams, this is not just a usability update. It is a design control, risk management, and submission readiness issue.

What FDA is signaling

Human factors work should not be treated as a late-stage activity or a “submission add-on.” FDA is making clear that the level of human factors information included in a marketing submission should be tied to the device’s risk profile, use-related hazards, critical tasks, and whether the submission involves a new device, a design change, or a new intended user/use environment.

In other words: FDA wants to see the logic behind your human factors strategy.

That means teams need to be able to explain:

• What use-related risks were identified
• Which tasks are critical to safety or effectiveness
• How risk controls were selected and verified
• Why the human factors information included in the submission is sufficient
• How the human factors work connects back to design inputs, risk management, labeling, training, and validation

Why this matters for Quality

Human factors is often viewed as a usability or regulatory deliverable. But when FDA reviews a submission, the human factors story needs to be supported by the quality system.

That includes the Design History File (DHF), risk management file, requirements traceability, design verification/validation records, labeling controls, complaint history, and change control documentation.

If those pieces are disconnected, the submission can become harder to defend. A human factors report may say one thing, while the risk file, design outputs, or labeling history tell a less complete story.

This is where quality teams play a critical role.

What teams should do now

1) Start with use-related risk, not the report template

Before deciding what to include in a submission, teams should confirm that use-related hazards and critical tasks are clearly identified and traceable. Human factors documentation should flow from the actual risk profile of the device, not from a generic checklist.

2) Connect human factors to design controls

Human factors evidence should tie directly to design inputs, design outputs, verification, validation, labeling, and risk controls. If a use-related risk leads to a design feature, warning, training element, or user interface change, that connection should be documented and easy to follow.

3) Treat changes as a trigger for reassessment

For design changes, labeling changes, new users, new use environments, or new indications, teams should evaluate whether the change affects use-related risk. The answer may not always require a full new validation study, but the rationale should be documented.

4) Make the submission story easy for FDA to review

FDA’s guidance is aimed at improving consistency and review efficiency. Sponsors can support that goal by organizing the submission around the risk logic: what changed, what risks exist, what evidence supports the controls, and why the level of human factors information is appropriate.

5) Don’t wait until submission prep

If human factors issues are discovered late, they can create rework across design, labeling, training, risk management, and validation. Building the human factors strategy earlier helps prevent late-stage surprises and keeps the DHF aligned with the regulatory story.

Keep an eye on FDA’s July Town Hall

FDA has also held a Town Hall on July 22, 2026 to discuss the final human factors guidance and answer industry questions.

For teams preparing medical device or combination product submissions, this is worth watching closely. Any clarification from FDA could affect how sponsors justify their risk-based human factors strategy, organize submission content, and connect usability evidence back to the DHF, risk management file, labeling, and validation records.

If your team is preparing a near-term submission, it may be worth reviewing your current human factors documentation before the Town Hall, then comparing your approach against any additional FDA clarification that comes out of the meeting.

A practical readiness checklist

Before your next device submission, ask:

• Are use-related hazards and critical tasks clearly defined?
• Is the human factors strategy tied to the risk management file?
• Are design inputs and outputs traceable to usability-related risk controls?
• Do labeling and training materials reflect the risk controls being claimed?
• Have recent design, labeling, or user-environment changes been assessed?
• Is there a documented rationale for the level of human factors information included in the submission?
• Can the reviewer follow the story without hunting across disconnected documents?

Bottom line

FDA’s final human factors guidance reinforces a practical message: human factors is not just about usability testing. It is part of the submission strategy and part of the quality system.

The strongest submissions will be the ones where human factors, design controls, risk management, labeling, and validation all tell the same story.

If your team is preparing a 510(k), De Novo, PMA, HDE, or combination product submission, QSN can help pressure-test the human factors strategy, DHF traceability, and risk documentation before they become review questions.