Dec 10, 2019

In a previous blog post, we reflected on our experiences participating in FDA meetings on various Human Factors (HF) topics to share advice on how to effectively prepare for these meetings. Now, we turn our attention to the “main event,” and share some thoughts on how to ensure a productive meeting and effective follow-up.

During the FDA HF meeting

  • Getting everyone watered, fed, and to the meeting on time. Feeling prepared is about more than speaking points and refining a presentation. Don’t forget about other important logistics while you’re focused on your discussion preparation. Plan out meal timing before the meeting to provide sustenance and save time on the “big day.” And, most importantly, equip people with the information – and transportation – needed to ensure early arrival to any on-site meeting at FDA. You’ll need time to check in with security at the parking lot, take a shuttle to the building where the meeting is being held, sign in, and go through security. Your airport travel experiences are highly applicable when it comes to visiting FDA – have your government-issued ID ready! When there’s a large group of attendees, some of our clients hire a shuttle service to take everyone from the hotel or other meeting space to and from FDA to simplify logistics and ensure punctuality.
  • Bringing what you need. Limit what you are bringing into the meeting, including laptops and other technology. Have one person on the team bring a laptop with the presentation as backup, but otherwise use good old-fashioned pen and paper for notes during the meeting. Unfortunately, you cannot record the meeting, so we recommend that everyone on the team take some level of notes in real-time to ensure nothing is missed. And, this should go without saying, but turn your phones off or place them into airplane mode during the meeting.
  • Sticking to the plan. Follow what you planned before the meeting in terms of roles and responsibilities. There might be need a to improvise, but try to leverage your preparations as much as possible. Rely on the person assigned to be the lead spokesperson – in general or for a for a specific topic – to seek additional input as needed. Expect that there might be last-minute changes, and “go with the flow.” You can plan diligently and thoroughly and FDA might still ask unexpected questions.
  • Agreeing to disagree. It’s possible that you and FDA might reach a “sticking point,” and cannot come to an agreement on a specific topic on-site. If this occurs, make sure you clearly understand FDA’s perspective and/or concerns, and then you can discuss offline internally and follow-up afterward. If there appears to be any uncertainty within the team, defer the discussion to follow-up rather than committing to something with which the full team might not agree. While you might be able to briefly mute your line and have a sidebar during a teleconference, this is of course not an option for in-person meetings with FDA representatives.
  • Assuming the best. Don’t be defensive in your responses. Answer the questions that FDA asks matter-of-factly, rather than assuming that they are trying to challenge you with their question. For example, if FDA asks to describe your training plan, describe your training plan! Don’t feel like you have to justify it, try and make it seem like more than it is, etc. – a simple question is usually just that.

After the meeting

  • Documenting the meeting minutes. Per FDA’s guidance, you must deliver meeting minutes to the FDA within 15 days of the meeting. Have the primary note taker collect key points from other attendees, type up the consolidated notes, and then circulate to others on the team for review before finalizing. There’s no need to provide a transcript of the meeting, or to indicate who said what and when. Instead, capture the key points of agreement and disagreement. FDA provides an example of a format for meeting minutes in Appendix 3 of their Q-submission guidance.
  • Continuing the discussion. If there are open items after the meeting, discuss internally how best to respond based on any discussion with FDA during the meeting. Sometimes, a follow-up email with the lead reviewer is sufficient to clarify next steps for a straightforward topic, and for sure to indicate agreement with an FDA request. In some cases, an additional meeting or teleconference might be required.
  • Sharing lessons learned. Soon after the meeting with FDA, share any lessons learned from the meeting with other stakeholders within your organization. This might include project- or product-specific takeaways, which can help shape methods or approaches for future projects, or more general notes about your experience about meeting with the FDA. Sharing your experiences will likely help others in the organization feel more comfortable about FDA interactions, and will make the process less mysterious.

Remember, FDA encourages outreach from manufacturers because they support the development of new medical devices, and want to ensure a smooth and successful process for all involved parties. It is best to ensure you are on the same page as FDA as early as possible to prevent the need to re-do any HF work during device development.

We realize that there will always be at least a little “performance anxiety” when it comes to meeting with FDA representatives on HF or other topics. But, we hope that the above input, as well as the preparation tips shared in our earlier post, can settle everyone’s nerves a bit and help ensure a productive and successful meeting.

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

Author

  • Allison Strochlic and Laura Birmingham

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