The FDA Pre-Submission is a way for companies to request feedback from the agency on potential and planned medical device, biologics and drug submissions. It’s a
great service to take advantage of, only we’ve found that it tends to get underutilized.
The Pre-Submission allows us to request formal feedback on your medical device before we make the move to submit our 510(k). This is known as a Q-Submission, which
under the guidance published by FDA, allows you to request the following:
Pre-Submission (what we’re focusing on here)
An informal meeting
An agreement meeting
Other (such as submission issues or risk determinations)