In December of 2022, the FDA released draft guidance[1] to aid medical device manufacturers in determining what information should be included in marketing submissions for medical devices using a risk-based approach. The guidance outlines how to determine a submission category, each category requires different amounts of documentation. This framework aims to improve the efficiency of FDA review by reducing the number of requests for additional information.
The submission category is determined 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 user-related risk analysis, 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)?
After assessing the device against the questions above, a submission category can be determined. The categories are described below:
- Category 1: Modifications were made to an existing device, with no changes to the user interface, intended users, uses, use environments, training or labeling. An example of this could be a cybersecurity update that does not impact the user interface. The submission for a device under this category should include a high-level summary of the human factors engineering assessment and processes conducted and a conclusion stating whether the user interface of the device has been adequately designed for intended users.
- Category 2: Modifications were made to an existing device with no impact on critical tasks or a new device with no critical tasks. An example of a change to an existing device could be a change to labeling with no effect on critical tasks. Submissions should include rationale for why there are no critical tasks or why no critical tasks are added or impacted. The submission should include a conclusion stating whether the user interface of the device has been adequately designed for intended users, high level summary of the human factors engineering assessment and processes conducted, descriptions of intended users, use, use environments, training, device user interface, and a summary of known use problems.
- Category 3: Modifications were made to an existing device with an impact to critical tasks or a new device with critical tasks. For example, an existing device could include a change in the user interface, or a new user group added to a critical task. These devices should include a comprehensive Human Factors report including Human Factors validation test results and address all critical tasks. If modified devices have critical tasks that were impacted but existing risk controls remain acceptable, then rationale should be included in the submission.
The guidance document makes it clear what should be included on a submission after modifications have been made to a device. Additionally, it includes examples to further explain what a submission for each category may look like.
Human factors engineering and usability are important pieces to ensure medical device safety and efficacy. Let us know how we can help you navigate your submission and Human Factors requirements.
[1] Content of Human Factors Information in Medical Device Marketing Submissions – Draft Guidance for Industry and Food and Drug Administration Staff (December 9, 2022)
