FDA Finalizes Human Factors Submission Guidance: Key Changes from the 2022 Draft
- Hannah Cutright
- 15 hours ago
- 4 min read
On May 29, 2026, the U.S. Food and Drug Administration (FDA) released the final version of its guidance, "Content of Human Factors Information in Medical Device Marketing Submissions.” The guidance updates the FDA's recommendations for the human factors (HF) information that manufacturers should include in marketing submissions and introduces several important changes from the December 2022 draft. This guidance applies to marketing submissions to the Center for Devices and Radiological Health (CDRH) and does not apply to any other centers within the FDA.
The most significant update describes a more flexible risk-based approach to determining when HF validation testing is needed. The final guidance provides manufacturers with greater flexibility and may reduce submission burdens for certain devices.
A Major Shift: New or Modified Critical Tasks No Longer Automatically Require Validation Testing
The 2022 draft guidance recommended new devices with critical tasks or modified devices with new or impacted existing critical tasks utilize HF Submission Category 3, requiring HF validation testing and a comprehensive HFE/UE report.
The 2026 final guidance introduces a new Decision Point D, allowing manufacturers to justify why validation testing may not be necessary even when critical tasks are present. The manufacturer should now evaluate the following to make this decision:
The user interface’s history of use for the intended use, users, and environment(s)
The complexity of the device’s user interface
The adequacy of existing risk control measures
According to the final guidance, devices with simple user interfaces that have critical tasks but are associated with a history of safe use and effective risk mitigations may fall into HF Submission Category 2, which does not require HF validation testing.
Previously, the draft guidance only recommended HF Submission Category 2 when a new device had no critical tasks or when a modified device did not introduce new critical tasks or impact existing critical tasks. The final guidance maintains this recommendation but also allows Category 2 submissions when the device is associated with new or modified critical tasks and the manufacturer provides a rationale explaining why HF validation test data is not necessary using considerations outlined in Decision point D.
The FDA states that HF validation test data is still likely needed for “devices with complex user interfaces […] and/or if the device type historically has been associated with known use error issues.”
Changes to HFE/UE Report Content
The final guidance also introduces several updates to the Human Factors Engineering/Usability Engineering (HFE/UE) report.
The guidance now includes HFE/UE report outlines for each of the three HF Submission Categories, and includes sample text for HF Submission Categories 1 and 2. HF Submission Categories 1 and 2 only require abbreviated versions of the full HFE/UE report required for HF Submission Category 3. The HF Submission Category 2 HFE/UE report should include Sections 1 through 4 of the typical full HFE/UE report, while HF Submission Category 1 HFE/UE report should only include Section 1.
The HFE/UE report Section 2 “Intended users, uses, environments, and training” and Section 3 “Device user interface descriptions” may now reference information elsewhere in the marketing submission instead of repeating it within the HF report. Manufacturers may still repeat this information when additional context is helpful.
Changes to Risk Analyses
The final guidance provided the following new recommendations for Use-Related Risk Analyses formatting:
Use-Related Risk Analysis (URRA) columns: The guidance separates the URRA column “potential hazards and clinical harm” into two columns “potential hazardous situation” and “potential harm to patient/operator.”
The FDA provided additional instruction for conducting a comparative URRA for modified devices. Manufacturers should:
Include all tasks associated with modified use scenarios.
Discuss whether modification-related risks remain acceptable.
Assess whether the changes warrant human factors validation testing.
Updated Definitions
The final guidance revised two key definitions:
“Abnormal use” is now defined as “Conscious, deliberate act or deliberate omission of an act that is counter to or violates normal use and is also beyond any further reasonable means of user interface-related risk control by the manufacturer.” This was previously defined as “An intentional act or intentional omission of an act that reflects violative or reckless use or sabotage beyond reasonable means of risk mitigation or control through design of the user interface.” The final definition narrows the circumstances in which manufacturers can categorize a use scenario or error as "abnormal use." Manufacturers may need stronger justification when excluding intentional misuse scenarios from their risk analyses.
“Use safety” is now defined as “Freedom from unacceptable use-related risk.” This was previously defined as “How safe a device is when used or the extent to which risks of harm resulting from use error for medical devices have been either reduced to an acceptable level or eliminated completely.” The final definition removed the expectation that risks of harm resulting from use errors can be eliminated completely and instead should be reduced as far as possible to the point that any remaining use-related risk is acceptable.
Date of Effect
The guidance states the FDA and manufacturers need a minimum of 60 days to update policy and activities. The Agency does not expect manufacturers to follow recommendations from the final guidance in submissions that are already under review or are received before August 1, 2026.
Key Takeaway
The 2026 final guidance establishes the FDA’s new expectations for human factors data in CDRH marketing submissions. Instead of automatically requiring validation testing whenever new or affected critical tasks are present, the Agency now allows manufacturers to provide a justification when validation testing may not be necessary even for devices with new or modified critical tasks that have not been previously validated. The FDA has adopted a more flexible, risk-based process that could reduce testing requirements and submission burdens for certain medical devices while still focusing on use-related safety.
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