Brandy Guarda, Regulatory Analyst in Washington, DC, contributed to the drafting of this post.
If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device? The US Food & Drug Administration (FDA) attempts to answer these questions in its recently issued draft guidance titled “Content of Human Factors Information in Medical Device Marketing Submissions” (the “Draft Guidance”). Once final, this guidance will complement and partially supersede FDA’s current guidance, “Applying Human Factors and Usability Engineering to Medical Devices” (the “Human Factors Guidance”), and supersede FDA’s draft guidance, “List of Highest Priority Devices for Human Factors Review.”Comments on the Draft Guidance are due by March 9, 2023, and may be submitted.
FDA’s 2016 Human Factors Guidance recommended eight different sections to include in a submission supporting a request for marketing authorization, an improvement over a complete lack of guidance on the subject. However, there have been gaps that the industry has struggled with because of the lack of guidance. For example, one of the recommended sections is “Section 8: Details of human factors validation testing.” The Human Factors Guidance provided that for modified devices, “the need to conduct an additional human factors validation test should be based on the risk analysis of the modifications.” However, the Human Factors Guidance did not provide further guidance on the risk analysis or whether the entire Section 8 may be omitted under certain circumstances.
In the Draft Guidance, FDA offers more details on when submitting only a subset of these recommended sections may suffice, providing a framework for first classifying submissions in three categories using a risk-based approach: (i) submissions for modified devices where the proposed changes do not affect the human factors assessment (Category 1, a low-risk category); (ii) submissions for devices not in Category 1 that do not raise certain issues of serious harm to the user (Category 2, an intermediate-risk category); and (iii) submissions for devices that raise certain issues of serious harm to the user (Category 3, a high-risk category). The framework then assigns the recommended minimum human factors information to each category: (i) Section 1 for Category 1, potentially requiring the least amount of information; (ii) Sections 1 to 4 for Category 2; and (iii) Sections 1 to 8 (ie, all recommended sections) for Category 3, generally requiring the most amount of information.
The table below, replicated from Table 1 of the Draft Guidance, summarizes what information should be submitted for each category:
In addition to providing the framework discussed above, the Draft Guidance deletes certain references to “safe and effective” in the Human Factors Guidance. For example, in the definition of “human factors engineering,” the Human Factors Guidance recites “to enhance and demonstrate safe and effective use” as the purpose of human factors engineering. The Draft Guidance instead states the purpose of human factors engineering is “to achieve adequate usability.” In a similar vein, the Human Factors Guidance requires a conclusion of safety and effectiveness for Section 1 of the human factors report, while the Draft Guidance instead requires a conclusion that the user interface is “adequately designed.” These changes seem consistent with FDA’s clarification in the Draft Guidance that human factors “constitute just one component” in FDA’s safety and effectiveness assessment, suggesting that a human factors report may not be the best place to reach the ultimate conclusion of a device’s safety and effectiveness .
The new framework and proposed changes will bring greater clarity to manufacturers who are preparing a human factors report for a device-marketing submission and should enable more efficient use of resources for both the industry and FDA.