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.
The 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.
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 us today 855.463.1633 | email@example.com |medinstitute.com.
Next time: What happens once I submit a Pre-Submission?
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