On 29 May 2026, FDA finally issued the final guidance “Content of Human Factors Information in Medical Device Marketing Submissions.” The draft version was issued in December 2022, so this final version has been expected for a while. The guidance applies to medical device marketing submissions to CDRH, including 510(k)s, De Novo requests, PMAs and HDE applications.
And honestly, this is a useful update.
Not because Human Factors suddenly became something new. It did not, it has been there always. Manufacturers have already been expected to consider human factors and usability engineering as part of device development, especially when use errors could lead to harm.
The useful part is that FDA now gives a clearer structure for what needs to be included in the submission.
This is an important and much-awaited clarification from FDA.
This guidance is not about how to perform usability engineering
One important point first: this guidance does not replace FDA’s earlier Human Factors guidance, and it is not meant to teach manufacturers how to perform a human factors evaluation.
Instead, the purpose is more practical from a submission point of view:
What Human Factors information should be included in the FDA application, and at what level of detail?
FDA describes this as a risk-based framework for determining the human factors information that should be submitted in a marketing submission. The aim is also to make the FDA review process more efficient by reducing unnecessary additional information requests.
In other words, this is not just another document to add to the pile.
It helps manufacturers explain the logic.
Timeline?
No need to panic!
FDA also recognizes that both industry and FDA need some time to implement the new recommendations.
For submissions that are already pending, and for submissions received before 1 August 2026, FDA generally does not expect manufacturers to already include all the newly recommended information from this guidance. FDA will, however, review the information if it is submitted.
But if your 510(k), De Novo or PMA is planned after that, this should definitely be considered already during submission planning.
And this is not just theoretical. FDA has already updated the nIVD and IVD eSTAR templates to include the content of the new Human Factors guidance, which means the new expectations are already finding their way into the practical submission structure. In other words: if you are preparing a new submission, it is a good idea to work with the latest eSTAR version and check early how the Human Factors section applies to your device.
Changes?
The biggest relief: clearer HF Submission Categories
For companies point of view, the most useful part of the guidance is the clearer categorization.
FDA introduces a risk-based approach where the amount of Human Factors information depends on the device, the user interface, the intended users, the use environment, the presence of critical tasks and whether a change affects those tasks.
In simplified terms, the guidance creates three Human Factors Submission Categories:
Category 1: limited HF information
Category 1 is the lightest level.
This may apply, for example, when a device change does not impact the user interface, intended users, use environment, training, labelling or how the user interacts with the device.
In these situations, the submission may only need a clear conclusion and high-level rationale explaining why the change does not affect the Human Factors assessment.
This is still not “no documentation”.
It means the logic needs to be documented clearly enough for FDA to understand why additional Human Factors information is not necessary.
Category 2: rationale, but not necessarily validation data
Category 2 is probably the most interesting category for many manufacturers.
This is where the manufacturer may need to provide more explanation, but not necessarily full Human Factors validation test data.
For example, if there are no critical tasks, or if a device modification does not introduce new critical tasks or impact existing critical tasks, the submission may fall into Category 2. FDA also emphasizes that the User-Related Risk Analysis should be considered for the final finished device, not only for the modified part of the device.
This is very relevant for software changes.
Not every software update automatically means that a new Human Factors validation study is needed.
The practical question is:
Does the change affect how the user interacts with the device, understands information, makes decisions, performs a critical task or controls the device?
If the answer is no, then a well-written rationale may be enough.
But the rationale must be clear. It should not be just one sentence saying “Human Factors is not impacted.”
Category 3: Human Factors validation data should be submitted
Category 3 is the most extensive level.
This is where Human Factors validation data should be included in the submission.
This is more likely when the device has critical tasks, the user interface is complex, the user group or use environment is new, or the risk controls need to be validated through actual user interaction.
FDA highlights factors such as user interface history of use, user interface complexity and the adequacy of existing risk control measures when deciding whether Human Factors validation data should be submitted.
This is also where the connection to URRA becomes very important.
You cannot really decide the Human Factors submission category properly if the use-related risk analysis is weak.
In practise?
For manufacturers, the practical message is simple:
Do not start by asking: “Do we need a usability (Human factors) test?”
Prefer questions like:
- Who are the intended users?
- What is the intended use?
- What is the use environment?
- What does the user actually do with the device?
- What information does the user rely on?
- What are the critical tasks?
- What could happen if the user makes a mistake?
- What risk controls are in place?
- Has anything changed compared to the previous device or version?
Only after this, it makes sense to decide whether the submission is Category 1, 2 or 3.
This is especially important for software and AI-based medical devices.
A change in software may be technically small but clinically meaningful if it changes what the user sees, how information is displayed, how alerts are triggered, how recommendations are presented or how the user makes a decision.
On the other hand, a software change may also be technically relevant but not meaningful from a Human Factors point of view if it does not affect the user interface, workflow, decision-making or critical tasks.
That is why the explanation matters.
My thoughts
I see this guidance as a positive update and I like the way it was written.
It does not remove the need for proper Human Factors and usability engineering work. But it gives manufacturers a clearer way to explain what has been done, why it is sufficient and what should be included in the FDA submission.
The biggest benefit is not that everything becomes easier.
The biggest benefit is that the expectations are more structured and it removes the uncertainty that what needs to be added and is there new Human factors Validation required.
And in FDA submissions, that matters a lot.
Because often the issue is not only whether the work has been done.
It is whether the logic is visible enough for FDA to follow.
For upcoming submissions, my recommendation is clear:
Start with the URRA. Identify the critical tasks. Assess whether the device or change impacts user interaction. Then define the Human Factors Submission Category and document the rationale clearly. Document everything so you don’t need to remember why you chose the pathway!
That is the part that can save time later and hopefully reduce unnecessary additional information requests during FDA review.
Small hint: do not forget to check clear example tables (like URRA) that FDA provides in the guidance!
Need help?
Not sure what Human Factors information your FDA submission should include?
Nometech can help you review your URRA, identify critical tasks, define the correct HF Submission Category and prepare a clear rationale for your FDA application.
The goal is simple: make the logic clear before the submission goes in.
Contact us and lets make you a great HF plan.