Dec 4, 2019

Meetings with the US Federal Drug Administration’s (FDA’s) Human Factors (HF) reviewers often yield helpful clarifications and a clearer path forward for a medical device’s development and/or commercialization. Those manufacturers that have attended an HF-focused meeting with FDA probably agree. But, others might feel like they have to “prepare for battle,” either because the manufacturer has a strained relationship with the Agency or a particular individual has previous experience with a contentious meeting on HF or other topics.

Based on Emergo by UL Human Factors Research & Design’s experience supporting clients in many FDA meetings, we can share several tips and insights on how to best prepare for a meeting with FDA HF reviewers. As Benjamin Franklin said, “By failing to prepare, you are preparing to fail.”

We focus on in-person meetings, for which there are some additional considerations, but most of the points apply to teleconferences as well. Furthermore, we focus on preparations related to a pre-submission meeting following the Agency’s review of an HF validation (formerly known as “summative”) test protocol. That said, most points also apply to early-stage discussions about planned HF work for a given development effort, as well as meetings about HF validation test results.

  • Scheduling the meeting. If you are submitting an HF validation protocol for review, you should propose potential meeting dates in your submission. FDA’s guidance on Q-Submissions indicates that you should aim for a meeting 60-75 days following your completed submission, and the Agency will try to schedule the meeting for one of the preferred dates.
  • Ensuring HF representation. When you submit your protocol or other document for review, ensure you indicate on the proper form(s) that the submission contains HF information. Once a meeting is scheduled, ask your primary contact at the FDA (typically the lead reviewer for your submission) to provide a list of meeting attendees. It can be difficult to catch names, roles, and divisions in real-time during the meeting, so having this list in hand will help you be more prepared. Having the roster also helps to ensure that you will have an HF reviewer present during your meeting, which is your “right” if you want to discuss HF-related topics. As such, if an HF representative is not included on the list, you can request that one attend.
  • Putting on your “FDA hat.” You might only receive written feedback from FDA on your HF protocol or test results within five days of the scheduled meeting. Trying to digest and prepare responses to the feedback within a matter of days could be challenging for several reasons. We strongly recommend doing rigorous “scenario planning” by considering the questions or data you submitted to FDA and identifying requests or concerns the Agency might have, and how you might respond. Scenario planning enables you to prepare your thoughts and potential responses before receiving FDA’s written feedback, and typically expedites your formal meeting preparations.
  • Preparing concise, compelling slides. The manufacturer is responsible for preparing any slides to be presented at the meeting. Although you can start the slides at any time based on your scenario planning efforts (see above), you might need to update them shortly before the meeting to reflect FDA’s formal, written feedback. You should present information clearly and concisely, describing FDA’s question or concern and then your response – in brief. You want FDA attendees to listen to your compelling, verbal comments, rather than reading slides. We sometimes like to start off with points of agreement, if there are any, prior to asking clarifying questions and negotiating some open aspects of the next steps. (Note that any presentation files for the meeting must be sent to FDA at least two days before the scheduled meeting. You will not be able to use your own USB cables, flash drives, or other equipment to connect to a computer or network at FDA’s facility.)
  • Conducting a mock meeting. Like politicians doing a mock debate, you are well-served to conduct a mock meeting, enabling manufacturer representatives with speaking roles to practice their comments and having others serve as the FDA representatives. Such a meeting also enables you to fine-tune your discussion points and ensure you have enough time to cover the planned topics. If you’re preparing for an on-site FDA meeting, your final run-through might be in a nearby hotel conference room the day of, or the day before, the real thing.
  • Assigning roles and responsibilities. As suggested above, not everyone has a speaking role. You want to identify who’s leading the meeting, who the leader will call on to address particular topics, and who is taking notes. Some of our clients have even developed a seating chart, especially when there will be a lot of attendees. The chart often indicates who will sit at the table flanking the primary speaker, and who will be in a second row next to the main table.

Part Two of our series of posts on managing medical device human factors meetings with FDA covers meeting attendance as well as meeting follow-up issues.

Allison Strochlic is Research Director and Laura Birmingham is Managing Human Factors Specialist at Emergo by UL’s Human Factors Research & Design division.

Learn more about FDA regulatory requirements and human factors considerations for medical devices:

  • Human factors engineering (HFE) research support for medical devices and IVDs
  • Medical device usability training and consulting
  • US FDA Pre-Sub (Q-Sub) consulting for medical device manufacturers
  • Webinar: Meeting FDA expectations for HFE activities