The path to premarket approval (PMA), 510(k) clearance, and other medical device submissions is filled with uncertainty. To help medical device manufacturers get their regulatory strategy questions answered early in the submission process, the FDA developed the Pre-Submission (also known as Q-Submission or Q-Sub) program. This white paper explains what Q-Sub is (and what it is not) and how to make the most of the program for improved FDA submissions and compliance.

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