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What is a Submission Issue Request (SIR)?
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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.

A SIR is a request for FDA feedback on a proposed approach to address issues conveyed in a marketing submission (i.e., PMA, HDE, De Novo request, 510(k), Dual, or BLA) hold letter, a CW hold letter, an IDE Letter, or an IND Clinical Hold letter. To further clarify the scope of SIRs, the following are considered appropriate marketing submission hold letters:

  • Additional Information Needed for 510(k)s, De Novo requests, CWs, and Duals;
  • Major Deficiencies, Not Approvable, Approvable with Deficiencies, Approvable Pending GMP, and Approval with PAS conditions for PMAs and HDEs;
  • Complete Response Letter for Biologics License Applications (BLAs);

The SIR is intended to facilitate interaction between FDA and the submitter to quickly resolve or clarify issues identified in these letters so that projects can move forward, and so that submitters are able to fully address outstanding questions and issues in their formal responses. Submitters are expected to provide a formal response to any letters received from FDA within the requested timeline regardless of whether a SIR is submitted.

Please note a SIR is not appropriate for discussing letters conveying final decisions, such as Not Substantially Equivalent, Withdrawals, and Deletions.

A SIR is not necessary for simple requests for clarification of issues in a letter where the involvement of management is not needed (e.g. minor clarification questions or administrative issues that can be addressed by the lead reviewer). A SIR is also not necessary to discuss issues while a file is under active review.

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