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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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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