How an FDA Pre-submission Enhances Your Usability Engineering Process

The U.S. Food and Drug Administration (FDA) offers manufacturers the opportunity to engage with the Agency before submitting their final submissions or applications, e.g. 510(k) submissions. Such interactions with the FDA are typically referred to as pre-submissions or Q-submissions. A pre-submission allows the manufacturer to get the FDA’s input before initiating larger activities, e.g., Summative Evaluation (Human Factors Validation Studies) and Clinical Studies. In their guidance, the FDA states, “A Pre-Sub includes a formal written request from a submitter for feedback from FDA that is provided in the form of a formal written response or if the submitter chooses, formal written feedback followed by a meeting.” The guidance is available here.

Benefits of Pre-Submission

Why prioritize a pre-submission?

A frequent concern we hear is reluctance to engage the FDA early because a pre-submission might extend the timeline by 2–3 months. While a pre-submission can add time, it must be weighed against the risk of a final FDA submission being delayed or not accepted. From a Human Factors/Usability Engineering standpoint, issues that commonly surface include Summative Evaluation (Human Factors Validation) study design or methodology problems, such as:

• Use errors tied to identified critical tasks that are better assessed through actual or simulated-use scenarios rather than knowledge tasks.
• Omission of one or more user groups expected by the FDA.
• Participant recruitment that does not align with current demographics.
• Incorrect categorization of critical vs. non-critical tasks.
• Critical tasks omitted from the scope of the Human Factors Validation study.

These are only a few examples of the feedback FDA may provide. The guidance
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
lists sample pre-submission questions, including human factors.

When do we recommend a pre-submission?

• Your use-related risk assessment indicates no use errors with the potential to lead to serious harm, and you want FDA’s concurrence on the absence of critical tasks so you can forgo a Summative Evaluation (Human Factors Validation Study).
• There is uncertainty about the study design or methodology of your Summative Evaluation.
• The intended user group is highly restricted and difficult to recruit, and you plan to justify surrogate or proxy participants whose capabilities and limitations sufficiently mirror the intended users.
• You are seeking FDA feedback on bridging strategies to leverage existing human factors data.
• Getting it right on the first submission is more important than rigid adherence to internal timelines.

Conclusion

Engaging FDA through pre-submissions aligns expectations and streamlines later marketing submissions. Early identification of potential issues enables appropriate mitigations, reducing the risk of delay or rejection during the final submission. Contact us to discuss how a pre-submission can benefit your current or next project.