December 16, 2022
By Emilee Stanczyk
The U.S. Food & Drug Administration (FDA) issued a new draft HFE guidance document, Content of Human Factors Information in Medical Device Marketing Submissions, on December 9, 2022. The guidance aims to help medical device manufacturers determine what evaluation information should be included in marketing submissions for medical devices. This blog summarizes the guidance and describes the submission categories and evaluation information needed for each category.
The new guidance is intended to complement the FDA’s final HFE guidance from 2016 – Applying Human Factors and Usability Engineering to Medical Devices. The new guidance outlines what evaluation information to include in a marketing submission, as noted above, but does not describe how to perform a human factors evaluation; this is where the 2016 draft guidance remains particularly relevant.
Determining the submission category and evaluation information to submit
The draft guidance document contains a flowchart that manufacturers can use to determine which of the three defined categories their marketing submission fits into based on answers to the following questions:
- Is the submission a modification to an existing device?
- (If a modified device) Are there any changes to the user interface, intended users, uses, or use environments, training, or labeling?
- Based on the use-related risk analysis (URRA), are there any critical tasks present (if a new device), or have any new critical tasks been introduced or any existing critical tasks been impacted (for a modified device)?
Below, we describe the three submission categories and, for each one, share a quick example and list the required evaluation information.
- Category 1 is for modifications made to an existing device, but no changes to the user interface, intended users, uses, or use environments, training, or labeling. For example, upgraded cybersecurity features that do not impact the user interface. Category 1 submissions should include a statement that explains why the device modifications do not “affect the human factors considerations of the modified device,” leveraging previous evaluations to provide a conclusion and high-level summary.
- Category 2 is for new devices that do not have any critical tasks or modifications made to an existing device (including changes to the user interface, intended users, uses, or use environments, training, or labeling) that do not add or impact critical tasks. For example, labeling changes that do not affect any critical tasks. Category 2 submissions should include a rationale for why there are no critical tasks (for new devices) or why no critical tasks are added or impacted (for modified devices). For all Category 2 submissions, HFE report sections 1-4 are expected to be submitted as well (more on this below).
- Category 3 is for new devices with critical tasks or modifications to an existing device (including changes to the user interface, intended users, uses, or use environments, training, or labeling) that add or impact critical tasks. For example, the addition of a new user group who is expected to perform critical tasks. Category 3 submissions should include a comprehensive HFE report (sections 1-8) that includes HF validation test results and addresses all critical tasks (for new devices) or new or impacted critical tasks (for modified devices). If any critical tasks were impacted (for modified devices), but existing risk control measures remain acceptable, provide that rationale in the submission.
We advise that any manufacturer going through the marketing submission pathway first seek the FDA’s “buy-in” on the chosen submission category.
New and updated HFE report content from the FDA
The new guidance also describes each HFE report section, reflecting some updates or expansions as compared to FDA’s final HFE guidance from 2016. Furthermore, the FDA switched the order of Sections 5 and 6, as listed below. Below, we list the HFE report sections and any notable changes from the outline the FDA published in 2016.
- Section 1: Conclusion and high-level summary. This section should now include a high-level summary of the use-related risks as well as a summary of the HFE process conducted (e.g., HFE analyses and evaluations, device-user interface modifications, HF validation testing) and analysis of the results.
- Section 2: Descriptions of intended users, uses, use environments, and training. The FDA provides more examples of “operational context of use,” explaining that it could include aspects related to training, device use across clinical applications, as well as setup, maintenance, cleaning, and reprocessing.
- Section 3: Description of device-user interface. For modified devices, the FDA suggests including a table comparing the proposed and existing devices. The FDA provides a sample table and suggests including images of the existing and modified UI components to complement a written description.
- Section 4: Summary of known use problems. No substantial changes.
- Section 5: Summary of preliminary analyses and evaluations. No substantial changes.
- Section 6: Analysis of hazards and risks associated with the use of the device. For modified devices in Category 3, manufacturers should submit an analysis comparing the modified device’s URRA to the existing device’s URRA. The manufacturer should include a justification if they determine new HF validation test data is not necessary when a device change modifies any task, associated harm, and/or risk mitigation measure.
- Section 7: Identification and description of critical tasks. For submission Category 3, manufacturers should create a separate table highlighting any new critical tasks and, if applicable, why the new tasks do not warrant new HF validation testing.
- Section 8: Details of HF validation testing of final design. No substantial changes.
Adopting the new draft guidance
The new draft guidance states that marketing submissions should demonstrate that the users were considered in the device design and that the device is safe and effective for the intended users, uses, and use environments. This is aligned with FDA’s final HFE guidance from 2016. The key impact of the new draft guidance is that it will likely relieve manufacturers of performing certain HFE tasks when they have made minor modifications to a marketed device.
We recommend seeking the FDA’s confirmation of appropriate submission categories and evaluation information to include. Any questions about how to best interpret and apply the new guidance should be discussed directly with the FDA.
Emergo by UL will be presenting a webinar on the new guidance in early January, where we will expand upon this article and describe the guidance, our interpretations and key impacts to medical device manufacturers’ HFE processes.
Emilee Stanczyk is Managing Human Factors Specialist at Emergo by UL’s Human Factors Research & Design (HFR&D) division.
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