Submission issue request (SIR)

A SIR lets the applicant check a proposed response with FDA before replying, which can save a round of further questions. It is tied to a specific pending submission and the issues in that letter.

A SIR is a request for FDA feedback via written feedback or a meeting on a proposed approach to address issues conveyed in a marketing submission hold letter, a CW hold letter, an IDE Letter, or an IND Clinical Hold letter.

FDA guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 2025), Section II.B, Submission Issue Requests (SIRs)