From draft to final guidance
On May 29, 2026, the FDA issued its final guidance for the content of Human Factors information in medical device submissions. This was an update to the draft version of the guidance issued in December of 2022. On July 22, 2026, the FDA held a town hall discussion of the guidance.
The 2022 draft guidance established three Human Factor Submission categories, along with a flowchart to help to determine in which category a submission might fall. The 2026 guidance retains these categories, but adds an important new decision point in category determination. The categories are based on risk assessment, and govern which documentation must accompany the submission.
Human Factor Submission Categories
HF Submission Category 1: These submissions must be accompanied by the conclusion and high level summary of human factor evaluation.
HF Submission Category 2: In addition to the conclusion and high level summary required for Category 1, Category 2 submissions require a description of the intended device users, a description of the uses of the device, an explanation of the environments in which the device may be used, and a description of training for use of the device. Category 2 submissions also require a description of the device user interface, and a summary of known, post market use problems.
Finally, Category 2 submissions must be accompanied by a detailed rationale for why human factor validation should not be submitted, based on analysis of critical tasks, user interface, and existing risk control measures.
HF Submission Category 3: Category 3 submissions must be accompanied by a Human Factors Engineering Report with HF validation testing.
In addition to all of the above requirements, Category 3 submissions must be accompanied by a Human Factors Engineering Report with HF validation testing, a summary of known use problems, a summary of preliminary HFE/UE analyses and evaluations. Category 3 submissions also require a use-related risk analysis (URRA), which includes an analysis of hazards and risks associated with the use of the device, identification and description of critical tasks, and details of the human factors validation testing in the final design.
Use-Related Risk Analysis Framework
The categories are based on a Use-Related Risk Analysis (URRA), which evaluates the following information:
User task: A specific task involving a medical device
Possible use error: Predicted wrong actions that a user could take, or actions they could fail to perform
Hazardous situation: Circumstances under which people, property, or the environment could be exposed to one or more hazards
Potential harm to patient and/or operator: Specific harm or harms that could be caused to the user or patient
Severity of harm: Harm severity on a scale generally provided by the sponsor
Whether the task is a critical task: Is this a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user?
Risk control measures: Which measures, such as labeling, instructions, text, user interface design choices, interlocks, failsafes, hardware or software measures, are in place to control risks to the patient or user?
Validation method for effectiveness of risk control measures: By what method have the effectiveness of those risk control measures been validated?
Decision Points in the Determination of Human Factor Category
The flowchart for determining the category into which any given submission falls remains more or less the same as it was in the 2022 guidance, but contains an important new decision point: Decision point D. Decision points A-C are the same as in the 2022 draft guidance.
Decision Point A: Modification to an Existing Device
Is the application for a modification to an existing device? If the application involves a change to a device with existing FDA marketing authorisation 510k, PMA, HDE, or de Novo, or if it is for a new device with the same or similar user interface as a prior legally marketed device, and is leveraging Human Factor information from a prior legally marketed device, the application moves on to decision point B.
If the application is for a completely new device without prior FDA authorization, or not a legally marketed device of the submitter’s own with a similar interface to leverage Human Factor information, the application moves on to decision point C.
Decision Point B: Risk Considerations Due to Device Change
If the application involves a change to the user interface, to intended device users, or uses for the device, or intended use environments, or device training, or labeling of the device, the application moves on to decision point C.
Otherwise, the submission falls into HF Submission Category 1.
Decision Point C: Introduction of a New Use Risk
Is a new use risk being introduced?
For new devices, based on the URRA, are any of the new tasks considered to be critical tasks?
For modified devices, there are two questions. First, are new critical tasks being introduced? Second, Are existing critical tasks being impacted?
If the answer to these questions is “no,” then the submission belongs to HF submission category 2. If the answer is “yes,’ then the application moves on to decision point D, the new decision point.
Decision Point D: Risk of Complexity or Historical Experience
Decision point D asks the question, should Human Factor test data be submitted?
The following questions apply. Does the product have a history of safe use or of known use errors? Is the device-user interface complex? Have existing risk control measures remained effective, or is there new risk information to consider?
The following types of submissions will likely require submission of Human Factor test data:\
Complex user interfaces (including programming, monitoring, and changing settings)
Device types with known use error issues
If the risk has changed compared to historical devices, if new risk information has emerged, or if the severity of harm has increased.
If it’s determined that Human factor test data should be submitted, the submission belongs to Category 3. Otherwise, the submission belongs to Category 2.
ESTAR
Even with the flow chart, it can be a complicated business, determining into which category a submission falls. The Electronic Submission Template and Resource (ESTAR) is an interactive PDF form that can guide applicants through the process of preparing and submitting their medical device submission. ESTAR provides a standardized, structured format that complements reviewers’ internal review templates, enhancing the quality of submissions, and helping applicants to ensure that their submissions are complete.
Use of the ESTAR template is mandatory for a number of types of submissions, including all medical device premarket notification (510(k)) and De Novo submissions (unless exempted) to the Center for Devices and Radiological Health (CDRH) or to the Center for Biologics Evaluation and Research (CBER), and 510(k) and De Novo submissions for combination products sent to CDRH or CBER. In addition, ESTAR is required for Dual 510(k)/Clinical Laboratory Improvement Amendments (CLIA) Waiver in vitro diagnostic (IVD) submissions sent to CDRH.
Use of ESTAR is voluntary for the following medical device premarket approval (PMA) application and supplement types to CDRH or CBER:
Original PMAs
PMA Panel Track Supplements (PTS)
PMA Real-Time (RT) Supplements
PMA 180 Day Supplements and 30-Day Notice/135-Day Supplements
Q-Submissions (Q-Sub) sent to CDRH or CBER (including pre-submissions, submission issue requests, informational meetings, study risk determinations, PMA Day 100 Investigational Device Exemptions (IDE) sent to CDRH or CBER
513(g) requests for information sent to CDRH or CBER