What the FDA expects in a human factors submission
Gideon Awolesi ·
On 29 May 2026, the FDA finalised its guidance on the content of human factors information in medical device marketing submissions. It replaces the draft from 9 December 2022. The guidance doesn't change how you do human factors work. It tells you how much of it to put in your submission, based on the risk of the change you're making. If you get the category right, you avoid sending far more than you need, or far less, and the review goes faster.
01The three human factors submission categories
| Category | When it applies | What you submit |
|---|---|---|
| 1 | A modified device where nothing changed in the user interface, the users, the uses, the use environment, the training, or the labelling | A conclusion and a high-level summary |
| 2 | There are no critical tasks, or no new or affected critical tasks, or validation data isn't needed | A rationale, with descriptions of the users, the interface, known use problems, and the URRA |
| 3 | Critical tasks are new or affected, and validation data is needed | A full human factors report, including validation testing of the final design |
You pick one category per submission. If a submission includes several changes, you consider them together.
02The four decision points
The guidance gives you a flowchart with four questions:
- Is it a modification to an existing device? If it's a new device, you go straight to the third question.
- Does the change affect the user interface, the intended users, the intended uses, the use environment, the training, or the labelling? If not, it's category 1.
- Based on your use-related risk analysis (URRA), are there critical tasks, or are existing critical tasks new or affected? If not, it's category 2.
- Given the interface's history of use, how complex it is, and how adequate the existing risk controls are, should you submit validation test data? If yes, it's category 3.
The guidance notes that a change can affect a critical task even if the task looks the same, for example if it changes how people perceive or think about it, or adds or removes steps.
03What goes in the URRA
The use-related risk analysis is the document every category above 1 depends on. The guidance suggests a table with one row per task, and these columns: task ID, user task, possible use errors, hazardous situation, potential harm, severity, if it's a critical task, the risk control measures, and how you validated them.
The task ID matters more than it looks. It's what lets a reviewer trace a task from the URRA through your risk management file to the validation test, and back again. For a modified device, the guidance suggests a comparative URRA that puts the existing device and the modified one side by side.
04What a full category 3 report contains
- A conclusion and high-level summary
- Descriptions of the intended users, uses, use environments, and training
- A description of the device user interface
- A summary of known use problems
- A summary of the preliminary analyses and evaluations
- An analysis of the hazards and risks associated with use
- The identification and description of the critical tasks
- The details of the human factors validation testing of the final design
Category 1 needs only the first section. Category 2 needs sections 1 to 4, plus the URRA from sections 6 and 7.
05When it applies
The FDA said it and industry may need at least 60 days to put the guidance into practice, and submissions received before 1 August 2026 generally aren't expected to follow it. Anything you submit now should.
If you're not sure which category your change falls into, or if your usability engineering file will hold up, our Usability Review checks it clause by clause against IEC 62366-1 and the FDA's guidance, in four weeks from €6,000.