The sixth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here, here, and here for the previous five.

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)). You have received comments from FDA, and met with them to discuss them. What’s next?

Minutes: Within 15 calendar days of the teleconference or in-person meeting, you will draft meeting minutes and submit them to FDA. FDA will review and edit the meeting minutes, if necessary, within 30 days of receipt. The final version will become the final record of the meeting or teleconference 15 calendar days after you receive FDA’s edits. If you disagree with FDA’s edits, you can submit an amendment and FDA will discuss them with you.

Don’t try to capture everything that was said, just important agreements (or disagreements) and action items. The process may seem tedious, but it is often a good opportunity to get further clarification on FDA’s thinking and to clear up any misunderstanding.

Issues needing further discussion: As mentioned in a previous post, you only have 60 minutes, so you may not have time to discuss some of the lesser points of disagreement. Many of these can be handled with supplements to the original Pre-Sub. Talk to your lead reviewer about how to structure the discussion.

FDA’s commitment: In the Pre-Sub guidance, FDA has committed to standing by their feedback, with the following conditions: information in the formal submission is consistent with the Pre-Sub interaction, the data in the subsequent submission do not raise new important issues, and no material issues have arisen since the time of their feedback, e.g., new scientific findings about risks.

It is not unreasonable to be wary of this commitment, especially the caveat about “new scientific findings”. If there is a long gap between the meeting and the final submission, consider whether you will need to double-back with FDA.

Future submissions: All of your work will go to waste if you don’t remind FDA what was agreed upon when your formal submission (e.g., IDE, 510(k), PMA) is submitted. Those formal submissions should include a copy your questions, FDA’s comments, the meeting minutes, detailed responses to each of FDA’s comments, and cross-reference to the same information in the main body of the submission.

For instance, suppose your Pre-Sub asked a question about the types of bench tests to be conducted. FDA responded that they agreed to the test matrix, but they wanted you to do two more tests. The meeting minutes reflect that you agreed to the first additional test, but not the second one. In this case, the appendix to the formal submission should include your original question, a clear statement that FDA agreed to it with reservations, and (1) a reference to the location of the agreed-upon tests in the main body, and (2) a well-supported justification about why the remaining test was unnecessary.

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Next time: Is the Pre-Sub Process worth the time and effort?