The U.S. Food and Drug Administration (FDA) today finalized its guidance titled “Content of Human Factors Information in Medical Device Marketing Submissions,” originally issued in draft form in December 2022. The notice of availability was filed with the Federal Register on May 28, 2026, with formal publication scheduled for today.
The document provides manufacturers and FDA reviewers with a risk-based framework for determining what human factors engineering and usability engineering information needs to be included in marketing submissions , including 510(k)s, De Novo requests, PMAs, and HDE applications.
The guidance introduces a tiered system called HF Submission Categories (1, 2, and 3), determined through a decision flowchart. The category a device falls into dictates the level of human factors documentation required.
- Category 1 applies when a modification has no impact on the user interface, intended users, intended uses, use environments, training, or labeling. A high-level summary and justification statement suffice.
- Category 2 applies when changes exist but no new critical tasks are introduced (or no existing ones are impacted), or when human factors validation testing is not warranted based on a documented rationale. This category requires descriptions of intended users, use environments, the device user interface, and a summary of known use problems.
- Category 3 is the most demanding. It applies when critical tasks are present or impacted and validation testing is needed. A full HFE/UE report is required, including the use-related risk analysis (URRA), detailed descriptions of critical tasks, and complete human factors validation testing results.
If your are applying to a new device, you will not be classed in category 1. Your risk assessement will determine wether you are in class II or III
FDA acknowledges that manufacturers and reviewers will need a minimum of 60 days to operationalize the guidance. For submissions already pending or received before August 1, 2026, the agency does not expect manufacturers to include the newly recommended information, though it will review it if submitted voluntarily.