Should I Request A Q-Submission For My Medical Device?
By Caitlin Bancroft, JD, RAC, senior regulatory affairs specialist, Pharmatech Associates
![GettyImages-1441662840-lab-team-communication-collaboration GettyImages-1441662840-lab-team-communication-collaboration](https://vertassets.blob.core.windows.net/image/41158367/41158367-dc3b-4e98-ba3a-c94fc031ac87/375_250-gettyimages_1441662840_lab_team_communication_collaboration.jpg)
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.
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