The fifth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here, and here for the previous four.
You have sent FDA a Pre-Submission (Pre-Sub; see FDA guidance here) to get answers to questions you want to know well before your formal submission (e.g., an IDE or 510(k)). For instance, your clinical study involves novel technology and/or methods to assess effectiveness and you want FDA’s buy-in before you go too far down the road. You are convinced of the methods, but you know they are new to FDA, so you want to explain them in a face-to-face setting and make sure they understand them. A few other questions have come up too, so you will cover them.
The meeting will only last 60 minutes, so you will need to focus your efforts on key points of confusion or disagreement. Here are some key points to consider:
- The guidance recommends that your formal presentation be limited to one-third of the allotted meeting time. We think even less is better. Can you say what you need to say in 10 minutes? The meeting is intended for discussion. If you spend too much time in your initial presentation, you will hear less of what they are thinking. We often use the format of “Here is our question; here is your response; here are our thoughts on your response; let’s discuss;” for each question that was raised.
- Do not spend time repeating previous information. Do not talk about your company; talk about the device only to briefly remind people of it and bring up any features that may be the subject of their questions and comments.
- Rehearse the presentation and the meeting dynamics before the meeting. Who is in charge of introductions? Who gives the formal presentation? Who manages the meeting flow and fields questions? To whom does the meeting manager turn when they can’t answer a question? To whom does the fielder redirect for various types of questions? What sort of questions will FDA raise? Who answers them and how? Who takes minutes? If you are bringing outside experts, make sure they understand what you expect of them.
- However, do not over-rehearse. Your manner should be relaxed, not antagonistic or stiff, but still keep your eye on the goal of getting to a mutually satisfying resolution. With only 60 minutes, you do not have time for getting sidetracked.
- Always start with thanking FDA for their comments. If you have points of agreement with FDA’s comments (e.g., you are willing to increase the sample size or use the animal model they suggested), then let them know that right away.
- “Why” is always a good question for these types of meetings. You want to understand why FDA said what they said. So just politely ask them. Once they have explained, you may find yourself in agreement with them! Or you can propose a different solution and/or explain in more depth why you took your original position.
- Do not bring new data into the discussion or, if you do so, be careful about how and when you do it. The guidance states that, in most cases, FDA will only be able to respond to the questions or issues that were included in your meeting request or background information, not on new information presented during the meeting. If you do bring up new information, it’s best to couch it with the caveat, “We know this is new information, but we think it is relevant…” and then try not to force an immediate response.
Should you have this meeting over the phone or in person? As you can see from the list above, much of this is far more effective when everyone can see each other. Conversations are more spontaneous and relaxed. People are less likely to speak over one another or wait overly long as can often happen on a conference call.
Here is a second reason to have your meeting in person. The written comments are the collective opinion of FDA. But when you meet with them in person, you may be exposed to a diversity of opinions and viewpoints within the Agency. Several times, we have come to realize that a particular FDA team member was driving what seemed to be an unreasonable request. When the entire team is assembled and we’ve had an opportunity to explain things further, FDA’s opinion changed.
Our regulatory team is happy to help at any stage along the way, including preparing for the meeting, but it is best for all to be involved from the very beginning. For more information, please contact us today 855.463.1633 | email@example.com | medinstitute.com
Next time: After the Pre-Submission meeting