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?

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