FDA provides additional examples, clarity in human factors guidance
The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what human factors (HF) information sponsors should include in premarket submissions for medical devices.
On 28 May, FDA published the final guidance, which includes additional risk-based factors that sponsors should consider when determining the human factors submission category, new examples in the appendices, and clarification about the scope of the guidance. While the guidance applies to marketing submissions for medical devices, including 510(k) premarket notifications, De Novo requests, and premarket approval (PMA) submissions, the final guidance also addresses combination products.
"Note that combination products can have additional risks and considerations and are not addressed in this guidance document," said FDA. "FDA encourages submitters to contact the appropriate Center and review division to discuss combination product-specific human factors concerns, as appropriate.
"The recommendations in this guidance are intended to be generally applicable for all medical devices reviewed by [the Center for Devices and Radiological Health (CDRH)]," the agency added. "If there are device-specific guidances or requirements, the applicable recommendations should, and applicable requirements must, be followed."
Regulators also emphasized that the final guidance isn't intended to supersede other device-specific guidances.
Under the section on how to determine the human factors submission category, FDA has added a new decision point on whether human factors validation test data should be submitted when considering the interface history of the intended use and its environment, device user interface complexity, and the adequacy of existing risk control measures. The agency said sponsors should assess the use-related risk analysis (URRA) when considering the decision point.
"For modified devices where critical tasks are impacted by the modification but existing risk control measures remain effective at eliminating or reducing the risk, submitters can consider providing a rationale in lieu of submitting new human factors validation testing," it added. "Such rationale should include objective evidence that the risk controls remain effective."
The final guidance includes additional examples for sponsors when a 510(k) device has already been cleared for the market and has undergone a modification. The scenarios include a reusable duodenoscope, a stereotaxic navigation system, a continuous glucose monitor (CGM), and an interoperable automated glycemic controller for use in the management of type 1 diabetes. It also includes additional examples when considering new devices for premarket submission.
The final guidance now includes three appendices that provide examples illustrating the types of information that should be included in a human factors report for HF Submission Category 1, HF Submission Category 2, and HF Submission Category 3.
FDA said it understands that it will take time for sponsors preparing to file submissions or those who have recently submitted to come up to speed with the final guidance and has tried to accommodate them.
"FDA recognizes and anticipates that the Agency and industry may need a minimum of 60 days to perform activities to operationalize the policies within this guidance," said the agency. "For regulatory submissions that are currently pending with FDA after publication of the guidance, as well as those submissions received before August 1, 2026, FDA generally does not anticipate that manufacturers will be ready to include the newly recommended information outlined in the guidance in their submission.
"FDA, however, intends to review any such information if submitted at any time," the agency added.
