The Lure of the FDA Q-Sub Meeting:
When (and When Not) to Call for One
Part 2: Planning for the Meeting(s)
Jim Kasic, Founder & Chairman, Boulder iQ
Part 1 of “The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One” covered how to tell if – and when – to request a Q-Sub meeting, including whether to do one in Phase 0. Here, we’ll continue with a brief discussion of strategic multiple Q-Sub meetings, how to plan the actual meeting and how to choose a meeting spokesperson.
Multiple Q-Sub meetings
The FDA does not limit the number of Q-Sub meetings a company may request. Between that and the fact that there’s no FDA charge, it can be tempting to mismanage the opportunity. Usually, one Q-Sub meeting, done well, will be sufficient. But in cases of complex products, ones incorporating new technology or devices with other “first of its type” characteristics, a company may strategically plan for two Q-Sub meetings.
The first may take the FDA from Point A to Point B; the second may go from Point C to Point D. This division, in the right circumstances, could provide the FDA the right type and amount of information on each set of questions to offer truly significant responses.
If thinking of doing two Q-Sub meetings, though, consider the Q-Sub timeframe: typically six weeks from submission to obtaining a written response or meeting. Attempting more than two Q-Subs in a 12-month period would be very difficult, if not impossible, because of that window and the length of the preparation process. Plus, if a company is looking for information from the Q-Sub meetings to help guide its development process, the time involved in multiple meetings may slow things down. It’s a careful balance, and one to weigh with a professional regulatory expert.
Planning for the Q-Sub meeting
Once you have decided on your needs, strategy and timeline, and have a Q-Sub meeting scheduled, it’s time to prepare for the actual meeting. In preparing, two key factors are critical: creating and sticking to a meeting agenda; and selection of spokesperson.
In terms of the agenda, understand that the FDA can provide Q-Sub responses in written form, or via teleconference or videoconference, per request of the submitter. Pre-COVID, in-person meetings were also available, and may return in the future. When meeting via teleconference or videoconference, the time limit is just one hour. You’ll need to manage that hour to allow time for background presentation, your four (maximum) questions, responses and any follow-on discussion with the FDA.
Most manufacturers find that preparing a short slide deck is useful in structuring the meeting, which could follow a timetable along the lines of the following.
• Introductions: 5 minutes
• Background information on company and product: 5 minutes
• Presentation of questions, response from FDA: 30 minutes
• Additional discussion, as needed: 15 minutes
• Conclusion: 5 minutes
The most common problem in planning and managing the meeting is that companies spend too much time providing background on the company and product. The FDA does appreciate, and need, some base information on the market for the device and how the device will meet market demands and needs. But if the manufacturer takes too much time going into details on company background and technology is, there will be problems. One, it could confuse the FDA. Two, the FDA won’t have time to address all the questions in a useful way.
Avoid the issue with proper preparation, focusing on the whole reason you are doing the Q-Sub meeting: to obtain needed input from the FDA so that you can make your product development process as effective and efficient as possible. During the meeting, work to keep discussion on topic, and proactively obtain closure on every topic before moving on to the next.
Selection of the right meeting spokesperson (for a teleconference, videoconference, or later on, an in-person meeting) is crucial. In almost all cases, the spokesperson should be the company’s regulatory professional. It may be an in-house employee or a consultant contracted by the company.
Why? Q-Sub meetings are designed to obtain regulatory information. A regulatory professional will be familiar with the process, and able to stay on topic and handle discussion with the FDA. If the FDA does not understand a question, or provides a response with which your company does not agree, the regulatory professional can engage in productive discussion.
Sometimes, though, a company will want its CEO, scientist or engineer to serve as the presenter. This is generally a bad idea. The problem is that the CEO is (rightly) focused on the big picture, not regulatory details. A CEO is all too apt to take too much time presenting company background and accolades on the device technology. Engineers tend to focus too much on details, while scientists will concentrate, of course, on the science behind the device.
Go with the regulatory expert, and then schedule a rehearsal of the Q-Sub meeting. Engage an employee or consultant with whom you are working to serve as the FDA representative. Just as you’d do with any important presentation, rehearsing will help you stay within your timeline and schedule, identify any issues and improve confidence.
A bad Q-Sub is a waste of everyone’s time. Q-Sub meetings can be great – for developers and the FDA – but make sure you request one only if and when you truly need it. Then, work with your regulatory expert to prepare, focusing on what you really want to get from the meeting to improve your development process and eventual regulatory submission.