Three Categories Now Decide Your Device's Fate at the FDA.

Do You Know Which One You're In?

If you are preparing a 510(k), De Novo, or PMA in the coming year, human factors is now part of every review. In May 2026, FDA finalized its guidance, Content of Human Factors Information in Medical Device Marketing Submissions, and it changes how you decide what usability evidence to include, and how much. The framework is risk-based, the submission categories are new to many teams, and the updated eSTAR templates now put the question front and center. Here is what changed and what to do about it.

What is happening

FDA issued the final guidance on May 29, 2026, replacing the December 2022 draft. It works as a companion to the 2016 guidance, Applying Human Factors and Usability Engineering to Medical Devices, which still describes the core process and FDA's expectations for usability engineering. The new document answers one focused question: what human factors information belongs in a marketing submission, and at what level of detail. FDA also updated the eSTAR templates so submitters now select a Human Factors Submission Category and provide the supporting information directly in the template. A public town hall was held on July 22, 2026 to walk through the changes.

Who should care

Any company filing a premarket submission with CDRH. That includes early-stage device and software as a medical device companies preparing a first 510(k), and scaling manufacturers managing a portfolio of modifications and new products. If your team owns regulatory strategy, design controls, or risk management, the category you select now shapes both the size of your submission and how closely your usability file gets reviewed.

The practical breakdown

Three submission categories

The guidance sorts submissions into three categories with increasing documentation expectations:

• Category 1 (modified devices only): a conclusion and a high-level summary of the human factors evaluation.

• Category 2: a rationale explaining why the device has no critical tasks (for a new device) or no new or impacted critical tasks (for a modification).

• Category 3: a full Human Factors Engineering and Usability Engineering (HFE/UE) report that includes human factors validation testing.

A critical task is a task that, if performed incorrectly or not performed, could cause serious harm, including death. That definition is the hinge the whole framework turns on, so getting your use-related risk analysis right matters more than ever.

Where new devices land

In practice, a new device with no critical tasks falls into Category 2, supported by a documented rationale rather than a full validation study. That makes your use-related risk analysis, or URRA, the centerpiece of the submission. If the URRA identifies critical tasks, the decision moves further down the flowchart.

The new decision point

The most substantive change is a new decision point, labeled D, added to FDA's flowchart. Under the 2022 draft, identifying a critical task pointed almost directly to full validation testing. The final guidance adds Decision Point D, which asks whether validation data needs to be submitted, based on three considerations: the user interface's history of use for the intended users, uses, and environments; the complexity of the user interface; and the adequacy of existing risk control measures. The result is more room to justify forgoing new validation testing when you have a well-understood interface and a strong safe-use history, provided the justification is backed by a robust URRA and objective evidence.

The QMSR connection

Decision Point D comes with a caveat worth noting. FDA ties it to the Quality Management System Regulation (QMSR) and its design verification and validation requirements, and recommends that human factors information be maintained by the manufacturer whether or not it is submitted to FDA. In plain terms, a lighter submission does not mean a lighter file. FDA can request your usability data during review, and your human factors records are fair game during a QMSR inspection. Teams that treat a Category 1 or 2 justification as a reason to skip the underlying work may be exposed later.

A reorganized outline and more examples

The final guidance also confirms a slightly reordered HFE/UE report outline, placing the preliminary evaluations summary ahead of two consecutive sections on the URRA and critical task identification, which helps tell a clearer risk story. It adds a much larger set of worked examples, including scenarios for special populations such as pediatric users, novel interfaces, and devices with a known history of use-related problems.

What to do now

• Revisit your URRA first. Category selection depends on it. Confirm whether your device has critical tasks and document the reasoning either way.

• Build your Decision Point D evidence. If you plan to justify forgoing validation testing, gather interface history of use, a complexity assessment, and evidence that existing risk controls are adequate.

• Map to the new outline. Structure your human factors documentation to the reorganized report outline so it is submission-ready.

• Keep an inspection-grade file. Make sure the records you keep internally are complete enough to withstand a QMSR inspection, not just an eSTAR upload.

• Review the eSTAR template early. Look at the updated template now so the category question does not surprise you late in the process.
  

The bottom line

The through-line is consistent with where FDA has been heading for years: usability is less about proving you ran a test and more about justifying, based on risk, what level of evidence is appropriate. Companies that keep a clean, traceable human factors file will find the new framework an opportunity to submit less, not more. Those that do not may find the flexibility works against them.

If you want a second set of eyes on where your device lands and what your submission should include, Rook's regulatory team can run a human factors submission-readiness assessment, mapping your URRA and documentation to the right category before you file.