The fourth in a series of blogs about informal, pre-submission contact with FDA. See here, here, and here for the first three.
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?
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. our regulatory team has considerable experience with Pre-Sub meetings. We are happy to help at any stage along the way.
For more information, please contact us today 855.463.1633 | email@example.com | medinstitute.com
Next time: The Pre-Submission meeting
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