The voluntary FDA Q-Submission Program, specifically the pre-sub meeting process, can serve as a powerful tool to streamline and optimize your medical device product development strategies, timelines, and budget, especially if you need to conduct a clinical study. In the first of a two-part article on this topic, we discussed the benefits of a pre-sub and shared five tips to prepare for a successful FDA pre-sub meeting for your clinical study. In this second part, which picks up after the pre-sub meeting has been scheduled and FDA has provided written feedback on your study design, we share five tips to successfully execute that meeting and manage post-meeting activities.
Tip #1: Follow meeting etiquette best practices
We recommend arriving 15 minutes before your scheduled meeting time. If you are meeting in-person, you’ll need the time to check-in and go through security, and if the meeting is virtual, you’ll want to ensure the technology is working properly. FDA usually opens the virtual meeting space 5-10 minutes ahead of the scheduled start time, so don’t be surprised if you cannot join until then.
Announce to FDA when all of your team members are present and ready to begin. FDA will kick-off the meeting with introductions and housekeeping items, including a reminder that you are responsible for taking the meeting minutes. When your designated note taker and slide manager are ready, your lead presenter can start by introducing your team and thanking the FDA for providing written feedback. If you desire an interactive meeting, which we recommend, encourage attendees to interrupt the presentation at any time. As you deliver your presentation, pause frequently to check in with your audience.
Tip #2: Focus on your critical outstanding questions
Like you, FDA has prepared for this meeting, so avoid rehashing the pre-submission documentation package. Stay focused on the critical outstanding questions and clarifications you strategically triaged (reference tip #4 in our previous article on this topic).
This is not the time for a monologue, and it’s okay if you spend more time on certain presentation slides than others. The FDA lead reviewer may moderate the discussion, but you may also ask direct questions of the medical, statistics, or other FDA representatives present. When you ask clarifying questions, pause to allow other FDA participants to elaborate, and then confirm your understanding. For example, you could say, “To confirm, I heard that FDA suggests modifying the inclusion criteria in [this way]” or “Do I understand correctly that FDA agrees a 6-month primary endpoint assessment is appropriate?” Await confirmation, then ask if there are any other comments before proceeding to the next point.
We know it is tempting to think about next steps, but avoid bringing up new strategies, data, or references. FDA cannot be expected to spontaneously advise on new information, especially if it involves a specialty area that is not represented by meeting attendees. For example, if your proposed clinical study design did not include randomization to a control arm, but during the meeting you and FDA conclude that randomization is necessary and appropriate, you should save your specific questions about the impact of that decision (e.g., sample size) for a pre-sub supplement.
Tip #3: It’s okay if you don’t know
Despite your extensive product knowledge and admirable meeting preparation efforts, FDA may still ask you a stumper of a question. Before you panic, stall, search, or worst of all – guess! – please know that FDA will respect a response of “I don’t know, but I can get an answer for you after this meeting.” You do not want to cause confusion by providing misinformation or lose precious discussion time searching your notes. When you have an accurate answer, you may return to the topic at the end of the meeting, provide it informally to the reviewer after the meeting, or incorporate it into the minutes.
Tip #4: Plan to debrief with your internal team
Schedule time to immediately debrief with your team to discuss the feedback and plan next steps. Did the meeting go as expected? Do you anticipate the need for a pre-sub supplement to resolve remaining questions, to raise new questions, or to propose new strategies? Are there any gaps or discrepancies in the meeting minutes recorded by your designated note taker that you can address as a group? Get everyone on the same page now, while the meeting is still fresh, to ensure the draft meeting minutes are accurate and clear.
Tip #5: Submit draft meeting minutes within 15 days of the meeting
The meeting minutes represent a high-level summary of discussion points and conclusions, so no need to record every word that every speaker uttered. This is not the place to record your next set of questions or to include your revised study synopsis that incorporates FDA feedback offered during the meeting. Plan to submit a pre-sub supplement for those types of updates.
Obtain the list of FDA attendees from the FDA lead reviewer and record their names on the meeting minutes, and if applicable, in the meeting presentation slide deck. To ensure your team agrees with the meeting summary, allow time for them to review the final draft minutes. Submit the final minutes and slide deck to FDA within 15 calendar days of the meeting. For the convenience of FDA editing, consider including a Word version of the document, as a “miscellaneous file” in the eCopy, or provide the file to the FDA lead reviewer via a courtesy email. Follow-up with the lead reviewer if you have not received edits or acceptance of the minutes within 40 calendar days.
Wishing You a Successful FDA Pre-Sub
We hope we’ve convinced you that pre-subs are an important part of your clinical study design process, helped you understand what to expect during the pre-sub process, and given you the confidence to prepare and execute a successful meeting. By negotiating your regulatory pathway and clinical study design strategies with FDA well in advance of submitting your investigational device exemption (IDE) application, you can reduce the risk of approval delays, thus streamlining your overall regulatory process and saving you time and money. It’s a BRIGHT Idea to connect early and often with FDA, and the pre-sub process is a great resource to do just that. BRIGHT Research Partners is here for you, too. Good luck!