On May 29, 2026, FDA finalized Content of Human Factors Information in Medical Device Marketing Submissions, replacing the December 2022 draft with a risk-based framework that sorts every marketing submission into one of three Human Factors Submission Categories. It is not a paperwork update. Since August 1, 2026, the eSTAR templates that most device submissions now run through prompt for that category explicitly — and there is no path around the question. Teams still working from the draft's flowchart, or from the 2016 guidance's task-list logic alone, are answering a question FDA no longer asks the way it used to.
Three categories, not a testing checklist
The guidance's Decision Point flowchart starts from the use-related risk analysis your usability engineering process already produces under IEC 62366-1: the task list, the critical-task determinations, and the known use problems. What FDA changed is what happens once that analysis is in hand. Instead of a single human factors engineering report template applied uniformly, the analysis now routes the submission into one of three categories, each with a distinct documentation burden.
What Decision Point D changed
The December 2022 draft had a hard edge: a "yes" at Decision Point C — the submission has new or impacted critical tasks — routed straight into Category 3, the most burdensome tier, with no further judgment applied. Industry comment pushed back on that as overbroad, and the final guidance answered it with a fourth decision point that sits between the critical-task finding and the Category 3 conclusion.
- History of use. Whether the user interface element in question has an established history of use for this intended use, these users, and this use environment.
- Complexity. Whether the interface or interaction involved is simple enough that the risk of use error is inherently low.
- Existing risk controls. Whether risk controls already in place — not proposed, already implemented and verified — adequately address the hazard the critical task presents.
A new or impacted critical task is no longer an automatic Category 3. It is the trigger to ask whether history of use, low complexity, and existing risk controls already do the job validation testing would otherwise have to prove. Reading Decision Point D correctly
eSTAR made the category unavoidable
The finalized guidance and the eSTAR update landed together by design. Beginning August 1, 2026, the revised non-IVD and IVD eSTAR templates — version 7.0 — prompt every submitter to select a Human Factors Submission Category and supply the information tier it requires; version 6.2 retired two days later. Human factors consideration is no longer something a low-risk 510(k) could quietly skip past. Even a Category 1 filing now has to say so, and say why, inside the template FDA reviews the submission against — which means the category decision has to be made and documented before the submission goes in, not reconstructed after a review question asks for it.
- Refresh the URRA. Confirm the use-related risk analysis reflects current user groups, known use problems, and an explicit critical-task list — the flowchart is only as reliable as this input.
- Walk Decision Points A–C. New device or modification, and does the risk file show new or impacted critical tasks. No critical tasks routes to Category 2 — write the rationale, do not just assert it.
- Weigh Decision Point D. History of use, interface complexity, and adequacy of existing risk controls — document the answer to each rather than assuming critical tasks force Category 3.
- Match the eSTAR record to the category. Category 1 gets a summary and conclusion; Category 2 gets a rationale; Category 3 gets the full HF engineering report with validation results on every critical task.
None of this changes what design controls already require of a usability engineering file — the task analysis, the risk file, the validation protocol when one is needed. What it changes is the submission-planning conversation: the category has to be decided, and defensible, before the clearance strategy is finalized, because a Category 2 rationale FDA doesn't accept on first review costs a review cycle a correctly-argued Category 3 submission would not have.
Frequently asked questions
What are FDA's three Human Factors Submission Categories?
Category 1 covers device modifications with low use-related risk impact, where a high-level summary and conclusion is enough. Category 2 covers submissions — new devices or modifications — where the use-related risk analysis shows no critical tasks, or no new or impacted critical tasks, and requires a documented rationale for that conclusion. Category 3 covers devices with critical tasks that need a full human factors engineering report, including validation testing designed to detect use errors on every identified critical task.
What did Decision Point D change from the December 2022 draft?
In the draft, a device with new or impacted critical tasks was routed straight into Category 3. The final guidance adds a fourth decision point that asks submitters to weigh the user interface's history of use in the intended use, users, and environment; the interface's complexity; and whether existing risk controls already address the identified hazards, before concluding that validation data is required. A submission can have critical tasks and still avoid Category 3 if those three factors support it.
Do low-risk device modifications still need to state a Human Factors Submission Category?
Yes. Since eSTAR's version 7.0 templates took effect August 1, 2026 (retiring version 6.2), every template-based marketing submission — not just ones with obvious usability risk — prompts the submitter to select a category and supply the supporting information it requires. A Category 1 submission is still short, but stating none is no longer an option.
Sources & further reading
- FDA. Content of Human Factors Information in Medical Device Marketing Submissions — Guidance for Industry and Food and Drug Administration Staff (final, May 29, 2026). federalregister.gov
- FDA. Applying Human Factors and Usability Engineering to Medical Devices — Guidance for Industry and Food and Drug Administration Staff (Feb. 3, 2016). fda.gov
This article is provided for general informational purposes and reflects the regulatory landscape as of August 2026. It is not legal or regulatory advice. Confirm current human factors submission requirements with FDA or qualified counsel before filing.
