FDA Human Factors for Medical Devices: Navigating the New Category 1, 2 & 3 Framework

Overview

FDA's 2026 Human Factors guidance has changed the way medical device manufacturers determine what human factors information belongs in a marketing submission. The May 2026 final guidance establishes a risk-based framework that places submissions into Human Factors Submission Categories 1, 2 or 3, while revised eSTAR templates now incorporate this decision process directly into the submission workflow.

The challenge is that choosing the correct category is rarely as simple as asking whether a device has critical tasks. Manufacturers must consider whether the submission involves a new or modified device, what has changed in the user interface, whether intended users or use environments have changed, whether existing critical tasks are affected, what the Use-Related Risk Analysis shows, and whether existing evidence is sufficient to support the submission. Even a device with critical tasks may not automatically require human factors validation data to be submitted, while seemingly limited device changes can create a very different result when they affect how users perceive, understand or interact with the device.

This webinar will walk participants through FDA's Category 1, 2 and 3 decision framework and show how those decisions connect to the URRA, critical-task analysis, human factors validation, supporting rationale and the Human Factors section of eSTAR. Particular attention will be given to Decision Point D, where factors such as history of safe use, user-interface complexity and the adequacy of existing risk controls can become central to determining whether validation data should accompany the submission.

Using practical device-change scenarios, participants will examine how the framework applies when software or controls change, labeling or training is revised, new user populations are introduced, the use environment changes, or several seemingly minor modifications collectively affect an existing critical task. The session will also clarify the boundary between FDA's submission-content recommendations and the broader human factors, design-development and risk-management activities manufacturers maintain under their quality system.

Areas Covered:

• FDA's 2026 Human Factors Submission Framework: What Changed
• Understanding Human Factors Submission Categories 1, 2 and 3
• Applying FDA's Decision Points to New and Modified Medical Devices
• Use-Related Risk Analysis (URRA) and Critical Tasks
• Determining When Human Factors Validation Data Should Be Submitted
• Building the Rationale When Validation Data Are Not Submitted
• Human Factors Validation Testing: Key FDA Expectations
• What FDA Expects in Category 1, 2 and 3 Submissions
• Completing the Human Factors Section in eSTAR
• Applying the Framework to Real-World Device Modification Scenarios
• Human Factors, QMSR and ISO 13485: Understanding the Boundaries

To support implementation of the concepts discussed during the webinar, attendees will receive the following handouts:

• FDA Human Factors Category 1–2–3 Decision & Submission Guide
• Medical Device Change → Human Factors Impact & Validation Decision Guide

Why Should You Attend?

The difficult part of FDA's 2026 Human Factors framework is not learning that Categories 1, 2 and 3 exist. The difficult part is determining which category applies to your device and what evidence supports that decision. A change to software, labeling, training, users or the use environment can affect the analysis differently, and the presence of a critical task alone does not provide the complete answer.

This program will help you work through those decisions the way FDA expects them to be evaluated. You will see how the URRA, critical tasks, existing human factors evidence, user-interface complexity, history of use and risk controls influence whether validation data should be submitted—and what a defensible Category 2 rationale or Category 3 submission should contain.

You will also see how these decisions translate into the revised eSTAR workflow and how they apply to realistic device-modification scenarios. The goal is to leave with a clearer process for determining what changed, what needs to be evaluated, what FDA needs to see, and how to support the conclusion before the submission reaches FDA review.

Who Will Benefit?

This webinar is designed for professionals responsible for preparing, reviewing, supporting, or approving human factors information for FDA medical device submissions and for teams involved in device design, usability, risk management, and regulatory strategy.

It is especially relevant to those who must determine the correct Human Factors Submission Category, evaluate critical tasks, support validation decisions, or complete the Human Factors portion of eSTAR; those include:

• Regulatory Affairs Directors
• Regulatory Affairs Managers
• Regulatory Affairs Specialists
• Medical Device Regulatory Submission Leads
• 510(k), De Novo, and PMA Submission Professionals
• Human Factors Engineers
• Human Factors and Usability Engineering Managers
• Usability Engineers
• User Experience Professionals Supporting Medical Devices
• Design Assurance Engineers
• Design Quality Engineers
• Quality Assurance Directors and Managers
• Quality Systems Managers
• Risk Management Professionals
• Medical Device Risk Management Engineers
• Product Development Directors and Managers
• R&D Directors and Managers
• Medical Device Design Engineers
• Systems Engineers
• Software and Digital Health Product Development Leads
• Clinical Engineering Professionals Involved in Device Usability
• Medical Device Safety and Risk Professionals
• Regulatory and Quality Consultants Supporting Medical Device Manufacturers