Q-Sub
The FDA program for asking for written feedback or a meeting, most often a Pre-Submission before a 510(k), De Novo, PMA or IDE. It is voluntary, and the feedback is not a decision on a later submission.
The FDA program for asking for written feedback or a meeting, most often a Pre-Submission before a 510(k), De Novo, PMA or IDE. It is voluntary, and the feedback is not a decision on a later submission.