Maximize FDA Pre-Submission value with strong follow-up. Capture clear meeting minutes, resolve open issues, apply FDA feedback to design and testing, and reference guidance in your submission for smoother, faster reviews.
Your Pre-Submission doesn’t end when the meeting adjourns or when you receive FDA’s written feedback. The post-meeting follow-up phase is crucial to maximize the value of the Pre-Sub. Here are some best practices to ensure you properly close the loop with FDA and implement their feedback:
If you had a meeting (teleconference or in-person), promptly draft the meeting minutes while the discussion is fresh in your mind. FDA expects sponsors to submit minutes within 15 days of the meeting. The minutes should capture the key points of discussion, any agreements or clarifications, and clearly state any FDA commitments or recommendations made during the meeting. Rather than a verbatim transcript, focus on outcomes – for example, “FDA clarified that Test X should be conducted for 10 cycles, not 5 as originally proposed,” or “Sponsor agreed to provide rationale for Y in the submission.” Once drafted, send the minutes to FDA within that 15-day window. FDA will review them for accuracy. If FDA suggests edits or corrections (they typically do so within 30 days), incorporate those. The minutes, once finalized, become the official record of what transpired and were concluded in the meeting. This record will be referenced in the future, so it’s in your interest to have it complete and accurate. (Tip: It’s wise to have had someone on your team designated as note-taker during the meeting to assist with this.)
It’s possible not every question got a black-and-white answer in the Pre-Sub – sometimes FDA feedback can be “We need to see more information on XYZ in your submission.” Take stock of any such open issues. Develop an action plan for each: maybe you need to run an additional test, gather literature evidence, or prepare a robust explanation for your submission. If something was left as a “to be determined” pending more data, consider whether it’s worth a follow-up Pre-Sub or simply to handle in the submission. FDA generally won’t entertain endless Q-Subs on the same topic in short succession, but if a new question arises from their feedback, you could potentially do another Pre-Sub. In many cases, though, you will carry these issues into the submission with appropriate documentation.
This might sound obvious, but it’s essential: integrate what you learned into your product development and testing efforts. If FDA suggested a particular test method, start planning that test. If they raised a concern about a risk, address it through design mitigation or labeling and document that. Essentially, use the feedback as a checklist for your next steps. Many successful companies turn FDA’s Pre-Sub comments into internal requirements that must be met before the submission is filed.
After the Pre-Sub, you generally shouldn’t be peppering the FDA reviewer with questions by phone or email – if new substantial questions arise, a new Pre-Sub is the formal route. However, it is acceptable to have some follow-up clarification by email for minor points (for example, confirming the FDA received your minutes, or a simple factual clarification). Use this sparingly. The FDA lead reviewer provided in your acceptance letter can be your contact. For example, “We are preparing the additional testing you recommended; just to confirm, you’d like to see 3 lots tested, correct?” – brief clarifications like that are often answered informally. Anything major should be either in the minutes or a new submission.
With the Pre-Sub concluded, you should update your regulatory strategy and timeline. Did the FDA feedback indicate you need to do a clinical study? Adjust your timelines and budget for that. Did they agree your data plan is sufficient? Great – you can move forward with confidence. Also, decide if you will need another Pre-Sub at a later stage. Some complex programs use multiple Pre-Subs (e.g., one early for device concept, one later focused on the clinical protocol). FDA allows this, though be mindful of not overusing the program without need.
When you reach the point of submitting your 510(k), De Novo, IDE, etc., make sure to explicitly reference your Pre-Submission interactions in the cover letter and within the submission. FDA actually encourages this: your submission should include a section that summarizes your prior Q-Sub communications and how you addressed the feedback in your application. Also, include the Pre-Sub Q-Submission number in your cover letter of the submission. By doing so, you enable FDA to quickly pull up the history. This helps because the person reviewing your 510(k) might be the same from the Pre-Sub, or it might be a different person – either way, linking the files lets them see “Ah, they already discussed these five points with us, and here is how they fixed them.” FDA has noted that when sponsors clearly explain how previous feedback has been addressed, it streamlines the review. For example, you might write in your 510(k) “FDA previously noted concern about X in the Pre-Submission; in this 510(k) we have included an additional analysis (see Section 10) that addresses this concern.” This demonstrates proactive compliance and can prevent re-hashing of issues.
After the Pre-Sub, gather your team and do an internal debrief. What went well? What would you do differently next time? Perhaps you discovered you should have asked an additional question – note that for future interactions. If there was any misunderstanding, figure out why and ensure your team is all on the same page with FDA’s position. Incorporate these lessons into your internal processes for regulatory planning. Over time, this makes your team more adept at interacting with FDA.
Even though the Pre-Sub is done, maintain the spirit of collaboration. In your future dealings with FDA (whether in the formal submission or additional communications), show that you value their input. For instance, if in your submission you deviated from what was discussed, acknowledge it and provide rationale. If you followed all suggestions, make that evident. The reviewers will appreciate that you took the Pre-Sub seriously, fostering continued goodwill.
By following up diligently, you ensure that the effort put into the Pre-Submission translates into tangible improvements in your device’s development and submission dossier. Companies that excel at regulatory submissions often cite strong follow-up and incorporation of FDA feedback as a key element of their success.
In conclusion, an FDA Pre-Submission is a powerful tool – but its power is fully realized only if you complete the cycle: ask, listen, and implement. By documenting the meeting, responding to FDA’s advice, and carrying those insights into your final submission, you greatly increase your chances of a smooth and successful review. Pre-Subs enable a more predictable pathway to market for your medical device, which is a win–win for both your company and the patients who stand to benefit from your innovation.
