A Pre-Submission (or Q-Submission) is a structured process for developing interactions between medical device manufacturers and FDA about a myriad of topics that ultimately point to future applications for approval or clearance, prior to the IDE, 510(k), PMA, or De Novo submission. Feedback is initially provided in written form but manufacturers can ask for a face to face meeting or—in these days of COVID—a web conference (note: the faces of the FDA participants are typically not shown). The Pre-Sub is only applicable to the questions you ask and not to any general FDA policies or appeals. Here are some recommendations you should think of before you submit.
- It can be invaluable to have an in-person meeting. Meeting the FDA face to face creates a personal relationship; they get to know you and more specifically your product. In this difficult time, however, video conferences are also possible. Although the FDA cannot turn on their videos during video conferences, you can share your screen to show the device or run an animated demonstration. If you can go onsite, bring a working version of your product if you can; do not expect the FDA to know or understand your product from the request. They are seeing the device and learning about it for the first time and their questions are important.
- BUT, don’t assume a Pre-Sub is necessary. A Pre-Sub takes time and may not be required. Determine the effect on your market release goal. For example, a Pre-Sub meeting is scheduled 70-75 calendar days from your request—that’s a long lapse of time. If you decide a Pre-Sub meeting is your preferred option, let MEDIcept help you make the most of meeting!
- Before the meeting, determine what is negotiable and consider creative compromises. Push the limits but be prepared to back down when necessary.
- Request the desired FDA personnel to attend the meeting within your submission—but choose wisely. Who do you want and what qualification should they have when reviewing your product? Also carefully think about who you will bring with you from your company. Pick your moderator to keep things flowing. You have an hour, sometimes a bit less. Does the engineer explain too much, does the consulting physician commonly speak of off label use, or does the CEO talk in marketing terms and not in the language of the FDA? One poorly placed statement can unravel everything.
- Carefully craft an Executive Summary in the Pre-Sub document. Create a PowerPoint presentation and make sure the two documents match. Only cover the major issues to which you need answers. Ask questions that have direct, specific answers and be precise; the Executive Summary may be the only thing some FDA attendees read before the meeting.
- Roll with the changes: FDA is allowed to give you feedback on your submission materials 5 days prior to the meeting. They may answer all of your questions, they may come up with some of their own. They may also give you a new topic to consider. It’s okay; stay on topic and revise your presentation to accommodate the feedback.
- Rehearse, rehearse, rehearse! Then rehearse again the day before the meeting; ensure all participants know their roles and are trained in FDA meetings. The calendar of an FDA staffer is very full, probably like yours. Make very good use of that time. Brainstorm likely concerns to be raised by FDA and practice how to respond to them.
- Have a fully capable, designated note-taker—but ask everyone to take notes. From the all the notes, craft minutes right after the meeting. Carefully capture important FDA agreements and concessions; don’t insert things you didn’t hear or didn’t say. This is the official record of the meeting and you may need to refer back to it with the FDA during the product review or an appeal.
The Pre-submission process can sometimes be difficult and how you talk to the FDA is very important; one wrong word can derail the whole meeting. Many times, it is best to use a trusted partner like MEDIcept. Annually, we help over 20 companies during FDA meetings.