The Q-Sub that doesn't buy you more time

Most people who have filed one call it “a Pre-Sub.” FDA’s own name for the program is broader on purpose: the Q-Submission Program covers five distinct request types, finalized together in a single guidance FDA reissued May 29, 2025 — replacing both the 2023 Q-Submission guidance and a separate 1998 policy on PMA Day 100 meetings that had stood on its own until this rewrite folded it in. A Pre-Submission is one door into that program. It is not the only one, and picking the wrong one costs a clock that doesn’t reset.

Five doors, five different questions

The guidance lays out a Pre-Submission for general feedback before a submission exists, a Study Risk Determination request for FDA to make the significant-risk-or-not call under 21 CFR 812.66 directly rather than leaving it to the sponsor and the reviewing IRB, an Informational Meeting for non-binding policy discussion with no submission-specific feedback attached, a PMA Day 100 Meeting to review a pending PMA’s status partway through, and a Submission Issue Request, or SIR, for one narrow purpose: discussing a planned approach to a problem FDA has already identified, in a letter FDA has already sent.

What an SIR is for, and the one thing it isn’t

An SIR reads, on the page, like exactly what a sponsor wants after a tough deficiency letter — a chance to talk the issue through with FDA before committing a formal response to paper. That reading holds for strategy. It does not hold for the clock. The guidance is explicit that an SIR is not a mechanism for FDA to pre-review a draft response and bless it for adequacy, and it does not extend, pause, or replace the deadline the original letter set. A sponsor who files an SIR and waits on FDA’s answer before finishing the formal response is not following the guidance’s own description of what the request does — the formal response is still owed on the date the letter named, whether or not an SIR is in flight.

The clocks are not interchangeable

A Pre-Submission carries FDA’s own commitment to written feedback within roughly 70 days of receipt, or five days ahead of a scheduled meeting if one is requested, whichever comes first — a real, separate clock built for a question asked before a submission exists. A Study Risk Determination request and a PMA Day 100 Meeting each run on their own timelines tied to what they’re answering. None of those clocks touch a deficiency letter’s own deadline, and an SIR’s clock — the time it takes FDA to discuss strategy — is not a substitute for any of them either. Five request types, five separate purposes, and only one of the five is built to move a deadline the sponsor is already holding.

The practice

Before filing an SIR against an open deficiency letter, calendar the formal response date as fixed and treat the SIR as a parallel conversation, not a hold on that date. FDA Radar’s own four sources — Federal Register notices, 510(k) clearances, device recalls, and CDRH warning letters — carry nothing about a Q-Submission of any type; a deficiency letter’s deadline and whatever a sponsor files against it live entirely outside what this product, or any monitor built from public FDA databases, can see. This is a description of how the Q-Submission Program’s request types and clocks are structured, never regulatory advice about how to respond to a specific letter.