Emergo Group’s Human Factors Research & Design team takes a closer look at new FDA HFE guidance for medical devices.
Emilee Stanczyk, Emergo Group
The FDA issued a new draft HFE guidance document, Content of Human Factors Information in Medical Device Marketing Submissions, on Dec. 9, 2022. The guidance aims to help medical device manufacturers determine what evaluation information should be included in marketing submissions for medical devices. This post 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submission, as noted above, but does not describe how to perform a human factors evaluation; this is where the 2016 draft guidance remains particularly relevant.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The draft guidance document contains a flowchart that manufacturers can use to determine which of the three defined categories their marketing submission fits into based on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.
Learn more about new and updated HFE report content from the FDA and adopting the new draft guidance at the Emergo Group’s blog.
Emilee Stanczyk is managing human factors specialist at Emergo by UL’s Human Factors Research & Design (HFR&D) division.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.