The Q-Sub Type Most Teams Skip — and the 60-Day Clock Attached to It

On May 29, 2025, FDA finalized Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, superseding the 2023 version, a 2024 draft revision, and a separate 1998 guidance on PMA Day 100 meetings. Ask most device regulatory teams what a Q-Sub is and they will describe a Pre-Submission — the meeting you request before you file anything. That is one type among several, and it is the wrong one for the moment that costs teams the most time: the weeks right after FDA sends a hold or deficiency letter on a pending submission.

More than one way to ask FDA a question

The Q-Submission Program is not a single mechanism wearing different labels. FDA's May 2025 final guidance groups several distinct request and meeting types under the Q-Sub umbrella, including the Pre-Submission (Pre-Sub), the Submission Issue Request (SIR), the Study Risk Determination, the Informational Meeting, and the PMA Day 100 Meeting. Each is built for a different moment in a device's regulatory life, and the type a sponsor chooses sets FDA's stated turnaround time — a fact that matters more once you are already inside a review than most Q-Submission and Pre-Submission strategy conversations acknowledge.

The Pre-Sub is for before. The SIR is for after.

A Pre-Submission exists to get FDA's input on specific questions that will guide product development or the preparation of a future 510(k) clearance or PMA filing — FDA has been explicit that it is not intended as a pre-review of an intended submission or of the data going into one. That is a forward-looking tool. A Submission Issue Request answers a different question: given a letter FDA has already sent on a pending submission, will the sponsor's proposed way of fixing it actually work? The letters that qualify span most of premarket review — Additional Information letters for 510(k), De Novo, and Dual submissions; Major Deficiency, Not Approvable, Approvable with Deficiencies, Approvable Pending GMP, and PAS-conditions letters for PMAs and HDEs; Complete Response Letters for BLAs; and IND Clinical Hold or IDE letters.

• 510(k), De Novo, and Dual submissions. An Additional Information letter qualifies for an SIR.
• PMAs and HDEs. Major Deficiency, Not Approvable, Approvable with Deficiencies, Approvable Pending GMP, and PAS-conditions letters all qualify.
• BLAs. A Complete Response Letter qualifies.
• Active clinical programs. An IND Clinical Hold letter or an IDE letter qualifies.

A Submission Issue Request is not a smaller Pre-Sub. It is FDA's answer to the specific question of whether your proposed fix will work — before you spend a review cycle finding out the hard way. Why the letter-response mechanism matters

Why the 60-day line is the one teams actually lose

The 60-day window rarely closes because a sponsor decided to wait. It closes because the letter goes through internal triage — regulatory, quality, and the technical team debating what happened and how to respond — before anyone drafts a question for FDA. Two or three weeks of that is normal. It is also most of the window. Once the SIR is filed after day 60, the stated aim moves to 70 days, which erases the entire advantage the mechanism was built to offer and lands the sponsor on roughly the same clock as if they had requested nothing more specific than a Pre-Sub. Against the backdrop of FDA's 2025-2026 restructuring and reviewer turnover, a self-inflicted 70-day wait is not a rounding error — it is a full review cycle a sponsor handed back voluntarily.

None of this changes what the letter says. It changes how long a sponsor waits to find out whether its proposed answer is the right one. Teams that route a hold letter straight to a scoped Submission Issue Request, inside the 60-day window, get FDA's read on their fix in roughly a third of the time it takes to get the same answer through a Pre-Sub-style request filed late. That difference compounds across every subsequent milestone in the submission.