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On May 29, 2026, FDA's Center for Devices and Radiological Health (CDRH) issued the final version of Content of Human Factors Information in Medical Device Marketing Submissions (docket FDA-2015-D-4599). The guidance replaces the December 2022 revised draft and, for the first time, formalizes a risk-based, three-category framework that determines exactly what Human Factors (HF) information manufacturers must include in 510(k)s, De Novo classification requests, PMAs, and HDE applications.
If your company prepares CDRH marketing submissions, this guidance changes how you scope, document, and defend the HF portion of every filing you make after August 1, 2026 — the date FDA expects submissions to begin conforming to the new recommendations.
Below is what the guidance says, what's actually new, and how to start preparing now.
What This Guidance Is
The new document is a companion to FDA's 2016 Applying Human Factors and Usability Engineering to Medical Devices guidance. The 2016 document tells manufacturers how to perform HF engineering. The 2026 document tells manufacturers what HF information to put in the marketing submission itself, and how the scope of that submission package should scale with use-related risk.
The guidance applies to CDRH marketing submissions only. Combination products are explicitly out of scope and continue to be addressed by the dedicated combination-product HF Q&A guidance. Device-specific guidances and special controls still take precedence over anything in this document.
The Three-Category Framework
FDA's central contribution is a four-decision-point flowchart that places every submission into one of three HF Submission Categories.
Category 1 — Modification with no HF-relevant change
This category applies when the submission covers a modification to an existing device and there is no change to the user interface, intended users, intended uses, intended use environments, training, or labeling. Category 1 sponsors must submit a written statement justifying that the modification does not affect HF considerations, along with a conclusion and high-level summary. Prior HFE/UE evaluations can be leveraged by cross-reference.
Note that even a labeling-only or training-only change disqualifies a submission from Category 1, because FDA defines those elements as part of the device user interface.
Category 2 — Critical tasks not impacted, or existing risk controls adequate
Category 2 applies when either (a) the device has no critical tasks (for new devices) or no new or impacted critical tasks (for modified devices), or (b) critical tasks exist or are impacted but HF validation testing is not required because of established user interface history of safe use, low UI complexity, and adequacy of existing risk controls.
Category 2 sponsors must provide a written rationale supporting the No answer plus the first four sections of the HFE/UE report: the conclusion, descriptions of users / uses / environments / training, the user interface description, and a summary of known use problems (typically supported by a MAUDE or TPLC search). For modified devices, a comparative use-related risk analysis (URRA) in Table 3 format is now expected.
Category 3 — New or impacted critical tasks, HF validation testing warranted
Category 3 is the most extensive package and applies when new or impacted critical tasks exist and HF validation testing is warranted. Sponsors must provide all eight sections of the HFE/UE report, including the preliminary HFE/UE analyses, a full URRA, identification and description of critical tasks, and a comprehensive HF validation testing section with rationale for test type (simulated use, actual use, or clinical study), participant numbers and types, training, success criteria, observations, use error analysis, design modifications, residual risk analysis, and the full test protocol as an appendix.
FDA notes that for devices with complex user interfaces — infusion pumps are called out by name — or known historical use-error issues, HF validation data "are likely needed." Novel technological features, new indications, new user populations, new use environments, new safety signals attributed to use error, and increased severity of possible harm are all triggers that can push a submission into Category 3 even when historically the device type did not require it.
Key Definitions Worth Remembering
FDA carries forward and reinforces several definitions from IEC 62366-1 and the 2016 HF guidance. A few worth quoting:
- Critical task: "A user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care."
- Use error: A user action or lack of action different from what the manufacturer expected, not caused solely by device failure, that did or could result in harm.
- User interface: All means by which the user interacts with the device — explicitly including packaging, labeling, training materials, physical controls, display elements, alarms, and logic of operation.
- HF validation testing: Testing at the end of development to assess user interactions and identify use errors that would or could result in serious harm. FDA prefers this term over "summative testing."
What's New Compared to the 2022 Draft
The final guidance is meaningfully different from the December 2022 draft in several ways.
The three-category framework with the four-decision-point flowchart is now formally adopted, where the draft had outlined the concept but left more ambiguity. The guidance now references the new Quality Management System Regulation (QMSR) — the amended 21 CFR Part 820 incorporating ISO 13485:2016 by reference, which took effect February 2, 2026 — which means HF records are now governed by ISO 13485 Subclause 7.3. FDA has expanded the example library to 14 hypothetical scenarios across 510(k) modifications, PMA modifications, and new devices, and added Appendices A, B, and C with sample report language and outlines for each category.
For modified devices, FDA now clarifies that the URRA should cover the final finished device, not just the modification, so that upstream and downstream effects are captured. The final guidance also accommodates a path where a rationale based on continued effectiveness of existing risk controls can substitute for new HF validation testing even when critical tasks are impacted — a notable accommodation that gives experienced sponsors room to defend a Category 2 submission for incremental changes to a well-understood UI.
Implications for Manufacturers
The practical takeaways for regulatory and quality teams are concrete.
Every submission now needs an explicit HF category determination, justified in writing. There is no longer a "do nothing" option, even at Category 1. The assigned category must be stated in the report conclusion.
The URRA is the central deliverable across all categories. Even Category 2 rationales lean heavily on a defensible URRA. Sponsors who do not already produce structured URRA tables in the Table 2 format should build that capability now.
A comparative URRA (Table 3 format) is the new norm for any device modification. If your 510(k) pipeline is mod-heavy — software updates, labeling changes, expanded indications — standardize on this format.
Labeling and training are inside the user interface. Labeling-only changes can no longer be assumed HF-irrelevant for the purposes of Decision Point B.
Indication expansions almost always push to Category 3 even with no device change, particularly for new user populations such as pediatric or non-expert users.
Known-use-problem reviews of MAUDE and TPLC are now an expected element of Section 4. Plan time and budget for these searches for every Category 2 and 3 submission.
Pre-Submission (Q-Sub) strategy is explicitly recommended for borderline Cat 2 vs. Cat 3 calls — a good use of regulatory bandwidth and one we frequently support clients with.
Effective Date and Transition
The final guidance was issued May 29, 2026. FDA does not expect submissions in flight before publication, or received before August 1, 2026, to conform to the new recommendations — but conforming early is encouraged, and FDA will review the information if submitted. Plan as though August 1, 2026 is your effective date.
HF documentation must, of course, continue to be maintained internally regardless of what is submitted, per QMSR / ISO 13485:2016 Subclause 7.3.10.
FDA Town Hall — July 22, 2026
CDRH is hosting a virtual town hall to discuss the final guidance and answer industry questions.
- Date: July 22, 2026
- Time: 1:00 – 2:00 p.m. ET
- Registration: Not required
- Submitting questions for discussion: Email HFPMET@fda.hhs.gov by June 12, 2026. Questions will not be taken live during the session.
Full event details are available on the FDA town hall page. The town hall is your single best chance this year to get clarification directly from CDRH's Human Factors Premarket Evaluation Team — we recommend that any sponsor with a 510(k), De Novo, PMA, or HDE in the pipeline plan to attend.
How Cosm Can Help
Cosm specializes in FDA regulatory and quality strategy for medical devices and Software as a Medical Device. If you are scoping a submission that will be affected by the new HF framework, building out URRA capability for the first time, or trying to defend a Category 2 rationale in lieu of HF validation testing, contact us or visit www.cosmhq.com to discuss how we can support your submission timeline.
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