Q-Submission and Pre-Submission Meetings with FDA

1. Key takeaways

The Q-Submission (Q-Sub) is the formal communication mechanism between FDA and an applicant. According to the FDA eSTAR Program page, the Q-Sub types supported by the PreSTAR template include: Pre-Submission, Submission Issue Request, Informational Meeting, Study Risk Determination, PMA Day 100 Meeting, and Accessory Classification Request. Under MDUFA V, a 60-day material submission rule is additionally tied to fee waiver eligibility.

• Q-Subs are voluntary in principle, but for high-risk programs they are effectively indispensable because they secure written FDA feedback before major resources are committed.
• A Q-Sub produces no approval conclusion; treating it as a pre-review is a structural misunderstanding of the mechanism.
• The 60-day rule is an eligibility rule for fee relief, not a courteous suggestion.
• PreSTAR version 3.1 covers all six Q-Sub types, so official structured templates can be used instead of self-organized documents.
• eSTAR use for Q-Subs is voluntary, unlike the mandatory eSTAR regimes for 510(k) and De Novo submissions.

2. Legal basis

The table below lists the sources defining the Q-Sub types, the MDUFA V 60-day rule, and the regulatory anchors for the accessory classification and study risk determination question types, all verified in 2026.

3. Expert insights

Insight 1: The Q-Sub is voluntary, but for high-risk programs it is in substance a necessity. A Q-Sub itself produces no approval conclusion, yet it allows the sponsor to obtain FDA’s written feedback on critical questions, such as the classification pathway, the clinical protocol, or predicate selection, before large resources are invested. For De Novo and PMA programs in particular, the marginal value of a Q-Sub far exceeds its time cost, because a single misjudged assumption corrected early can save an entire development cycle.

Insight 2: The 60-day rule is an eligibility rule, not a polite suggestion. Under the MDUFA V provisions recorded in 90 FR 35895, the applicant must submit the meeting materials within the prescribed period (60 days) before the planned meeting request, otherwise the associated fee relief does not apply. This rule converts early preparation of meeting materials from a best practice into a financial necessity. Teams that treat the materials deadline loosely should understand that the consequence is loss of eligibility, not merely a slower meeting date.

Insight 3: The scope of PreSTAR continues to expand. PreSTAR version 3.1 now covers six Q-Sub types; earlier versions covered only the Pre-Submission, IDE, and 513(g). This means sponsors can prepare Q-Subs directly on the official structured template rather than assembling their own document formats. Using the current version also reduces the risk that questions arrive in a structure the reviewing division must first re-map.

Insight 4: eSTAR use for Q-Subs is voluntary, in contrast to the mandatory regimes for 510(k) and De Novo. According to the FDA eSTAR Program page, PMA, Q-Sub, IDE, and 513(g) all appear in the voluntary use section, while 510(k) and De Novo appear in the mandatory use section. Keeping these two lists straight is essential, because assumptions carried across from a mandatory context, or the reverse, lead to filing errors on both sides.

Viewed together, these four points describe a mechanism whose value depends entirely on how deliberately it is used. A Q-Sub asked of a half-formed question returns half-formed guidance, while a Q-Sub built on a precise question list, submitted through the current template within the eligibility window, returns written feedback that anchors the later dossier. The difference between the two outcomes is preparation discipline, not chance, and that discipline is entirely within the sponsor’s control. Programs that treat the Q-Sub as a scheduled deliverable with its own owner and deadline consistently extract more value from the same one or two interactions FDA will entertain before the formal submission arrives.

4. Practical recommendations

• Schedule the Q-Sub at the launch stage of De Novo and PMA programs, so that pathway disagreements are resolved before submission.
• Back-plan the preparation of meeting materials against the 60-day rule to avoid forfeiting fee relief eligibility.
• Prepare the Q-Sub using the current PreSTAR version (3.1).
• Archive FDA feedback and respond to each point individually in the formal dossier, creating a traceable chain.
• Frame every submitted question so that it can be answered with a clear yes, no, or a specific recommendation, rather than an open invitation to comment.
• Do not treat the Q-Sub as a pre-review; it produces no market authorization conclusion of any kind.

5. Verification checklist

• □ Required Q-Sub type determined (one of the six types).
• □ Value of the selected Q-Sub type confirmed against the program’s key open questions before filing.
• □ Meeting materials prepared in compliance with the 60-day rule.
• □ Prepared using the current PreSTAR version (3.1).
• □ List of questions for discussion explicitly stated in the meeting request.
• □ FDA feedback archived, with point-by-point responses planned for the formal dossier.
• □ Confirmed that the Q-Sub produces no market authorization conclusion and no shipments scheduled on that basis.
• □ Internal owner and deadline assigned for the Q-Sub deliverable, matching the pace of the overall program plan.

One further habit distinguishes effective Q-Sub users from frustrated ones: the question list is written so that each question can be answered with a clear yes, no, or a specific recommendation. Open-ended invitations to comment produce open-ended responses that are hard to operationalize, whereas sharply framed questions yield feedback that can be transcribed directly into dossier decisions. Reviewing the question list against this test before the request is filed is a low-effort step that measurably improves the usability of the feedback that comes back.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com