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How should you link your Q-Submission to future regulatory submissions?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Many Q-Subs are followed by marketing submissions, IDEs, INDs, CWs, and/or supplementary Q-Sub interactions. These follow-on submissions are considered “related submissions” if they are for the same device and indications for use as the original Q-Sub. To help link Q-Subs to their subsequent related submissions, the submitter should identify the relevant Q-Subs in the cover letter of the subsequent related submission. If the relevant Q-Subs are not identified in the cover letter of the subsequent related submission, they will not be linked in FDA’s records. Therefore, there may be a delay in determining FDA’s previous feedback, and the subject device may not be incorporated in any future analyses of Q-Sub program effectiveness.

In addition, the related submission should include a section that clearly references the previous communication(s) with FDA about the subject device (or similar device) and explain how any previous feedback has been addressed within the current submission. This discussion of previous feedback will streamline FDA review even if the submitter elects to address FDA feedback with alternative methods to those discussed during the previous interactions.

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