What happens once I submit a Pre-Submission? (Part 1: Before the meeting)

The fourth in a series of blogs about informal, pre-submission contact with FDA.  See here, here, and here for the first three.

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You have sent FDA a Pre-Submission (Pre-Sub; see FDA guidance here) to get answers to specific questions well before your formal submission (e.g., an IDE or 510(k)). For instance, your technology is very new to the medical device world and you want to make sure that FDA agrees with your testing plan. What happens next?

  1. Initial acceptance review; setting the date. FDA will perform an “acceptance review” within 15 calendar days of receipt to make sure all the required elements of a Pre-Sub have been included in your submission. After that, they will contact you about setting a date and time for the in-person meeting or phone call.
  2. FDA internal review. The meeting typically occurs about 90 days after receipt of the Pre-Sub, with a commitment to provide you written feedback a few days before the meeting. FDA will create a team to review the matter, discuss your questions, and finalize their comments. You may get a phone call or email along the way, asking for clarification. As the meeting date approaches, it is advisable to reconfirm the date and time as well as FDA’s proposed list of attendees. Make sure that your expertise matches theirs. If they are including an engineer or statistician, make sure you have one too.
  3. FDA’s written feedback. FDA will answer your questions and provide you with additional comments. Those additional comments are as valuable as the answers to your questions. If the feedback is all positive, you may decide to cancel the meeting, but in our experience there are always more questions to be discussed.
  4. Before your meeting with FDA. The guidance states that FDA wants your presentation slides at least two business days before the meeting, but since you will have just received FDA’s comments, you will probably spend most of your time sorting out how you want to respond,so don’t feel an obligation to send the slides.

In our experience, the time between receiving FDA’s comments and preparing for the meeting is usually very intense. You have received feedback on your questions. You have likely received extra feedback. Some of it is clear, some of it is not, some of it is adverse, and some of it is supportive. Your meeting will last only 60 minutes. What topics do you cover?

It helps to remember that the Pre-Sub program is a process. You may need to come back later, perhaps via email, to discuss some of the minor points. MED Institute has considerable experience with Pre-Sub meetings. We are happy to help at any stage along the way.

For more information, please visit our website at http://www.medinstitute.com

Next time:  The Pre-Submission meeting.

What is involved when submitting a Pre-Submission?

The third in a series of blogs about informal, pre-submission contact with FDA. See here and here for the first two.

You have decided to ask FDA a question or questions that you want answered well before your formal submission (e.g., an IDE or 510(k)), so that you can save valuable time and money in the long run. For instance, you want to know if you’re doing the right large animal study or have the correct sample size for your expensive bench test.

RegulatoryThe Pre-Submission (Pre-Sub) program (see FDA guidance here) describes the contents of the submission you need to write  to get your questions answered. It is a long guidance, but not too hard to understand, especially if you have a specific product in mind. We’ll use this blog to cover some strategy and tactics we’ve learned over the years about what should go in the submission itself.

  • Cover Letter: This is fairly boilerplate. Introduce yourself, ask for the meeting, propose at least 3 dates to meet or talk, state who is attending, and who from FDA you want to attend. FDA typically limits the meetings to 60 minutes, so if you have a great deal to discuss, you can always plan on more than one Pre-Sub interaction; for example, the first to discuss non-clinical testing and the second to discuss a clinical protocol.
  • Device Description and Indications for Use: The “Goldilocks” principle applies here. Not too much, not too little. Write enough so that FDA can understand the questions you are asking, but don’t provide unnecessary detail.
  • Previous discussions or submissions; Overview of product development: Keep it brief. FDA doesn’t need to know the details.
  • The background for the question you are asking: This is the key section of the submission and, again, the Goldilocks principle applies. You want to give them enough background to understand the questions you are asking and the information that supports your proposed or desired answer. Answer possible objections, but don’t add details that aren’t relevant or else FDA may misunderstand your position.
  • Specific questions: Figuring out which questions to ask and how to ask them can be a challenge. Don’t ask, “What should I do?” Instead ask, “Do you agree with this approach?”
  • Method for feedback (writing only, meeting, phone): We strongly encourage you to meet with FDA in person at least once. It helps them feel comfortable with you. It helps you understand them better.

There is so much more to writing a Pre-Sub than these brief highlights. Each Pre- Sub has its unique challenges and all of them must be written carefully. We would be happy to be a sounding board, coach you through the process, write the submission for you, and/or coordinate the meeting.

For more information, please contact MED Institute via our website at http://www.medinstitute.com.

Next time:  What happens once I submit a Pre-Submission?