Should I Request A Q-Submission For My Medical Device?

By Caitlin Bancroft, JD, RAC, senior regulatory affairs specialist, Pharmatech Associates

For any medical device submission, the most powerful source of information will always be communication with the FDA. Q-Submissions are a mechanism available to request feedback from the FDA. It is the pathway for a medical device sponsor to reach out to request a meeting or written responses related to a product’s regulatory strategy or testing plan.

The time and money for a Q-Submission pales in comparison with what is needed to correct testing and regulatory strategies resulting from unexpected feedback at the time of a marketing authorization submission. Examine why a Q-Submission is almost always worth it and how to optimize the opportunity.