FDA Q-Submission Program

A Q-Submission is the formal mechanism for a device sponsor to ask the FDA a question, propose a study, or request a meeting, in writing, before a marketing or investigational submission. The June 2023 guidance consolidated several historical mechanisms into one program. Each Q-Sub gets a unique 'Q' tracking number and the FDA's response is binding within the bounds of the information provided — a sponsor who follows Pre-Sub feedback has a much stronger position when the eventual submission is reviewed.

• Pre-Sub — written request for FDA feedback on a planned submission (most-used member).
• Submission Issue Request (SIR) — feedback during review of an existing submission with an Additional Information request.
• Study Risk Determination — confirmation that a planned study is non-significant-risk under IDE rules.
• Informational Meeting — sponsor presents new technology to FDA reviewers without asking a specific question (read-only).
• PMA Day-100 Meeting — statutory meeting 100 days after PMA filing to discuss review status.
• Breakthrough Devices Program interactions — designation request, Sprint Discussions, Data Development Plan.
• Agreement Meeting and Determination Meeting — pre-PMA mechanisms for protocol agreement.
• Accessory Classification Request — request to classify an accessory under section 513(b).

A well-constructed Pre-Sub is short, specific and bounded. FDA expects:

1. Cover letter naming the planned submission type, expected timing and the meeting format requested (written feedback only, teleconference, or face-to-face).
2. Device description sufficient to ground the questions — intended use, indications, technology, predicate or comparator landscape.
3. Regulatory history — prior FDA interactions, related Q-numbers, any 483/Warning Letter context.
4. Specific questions, each numbered, each with a proposed sponsor position and the supporting rationale. The FDA answers the questions; vague open-ended prompts get vague answers.
5. Supporting data attached as appendices — pre-clinical, bench, clinical pilot, literature.
6. Proposed meeting agenda if a teleconference or face-to-face is requested.

Plan Pre-Subs so feedback lands at least 60 days before the planned submission to allow rework.

Q-Submissions do not carry MDUFA user fees. They are free to file. The cost is internal — preparing a Pre-Sub of acceptable quality typically takes a multidisciplinary team several weeks.

• Novel intended use or indication that does not fit cleanly into an existing classification.
• Predicate-selection uncertainty for a 510(k) — confirm FDA agrees the chosen predicate is appropriate.
• Clinical study design — endpoints, sample size, comparator, statistical plan.
• Non-clinical test plan — biocompatibility battery, electrical safety standards version, software documentation level.
• Cybersecurity documentation strategy under the 2023 premarket guidance.
• Real-World Evidence strategy — whether RWE is acceptable as a pivotal-trial substitute.
• Combination-product jurisdiction questions (CDRH vs CDER vs CBER lead centre).

• Asking 'Do you agree our device is substantially equivalent?' — FDA will not pre-decide the submission. Ask about the building blocks instead.
• Submitting a Pre-Sub before the device is well-enough characterised — FDA pushes back asking for clarifications, wasting the cycle.
• Bundling too many unrelated questions into one Pre-Sub — split into separate Q-Subs.
• Ignoring previous Pre-Sub feedback in the eventual submission — reviewers cross-reference.
• Treating Pre-Sub feedback as binding when material new information emerges — file a follow-on Pre-Sub or SIR rather than assume the original answer still holds.

FDA's eSTAR templates include Q-Sub formats. Q-Subs supporting a planned 510(k) increasingly use eSTAR for consistency. Use the latest template version available on FDA's eSTAR program page, and the FDA Customer Collaboration Portal for submission and tracking.