Medical DevicesLast reviewed April 2026

Q-Submission(Q-Sub)

FDA's formal mechanism for device sponsors to obtain feedback on development plans, submission content, or regulatory strategy before filing.

Usage Examples

The team filed a Pre-Submission to obtain FDA feedback on the proposed predicate and bench testing plan before finalizing the 510(k).
A Study Risk Determination Q-Sub confirmed the clinical investigation qualified as non-significant risk.
FDA's Pre-Sub feedback reshaped the performance testing matrix and saved a likely Additional Information request post-filing.

What is Q-Sub?

A Q-Submission (Q-Sub) is a voluntary interaction between a device sponsor and FDA CDRH to obtain written feedback on specific regulatory, clinical, or technical questions before committing to a full 510(k), De Novo, PMA, or IDE filing. Q-Subs are filed through the CDRH Portal and typically reviewed in 60-90 days depending on Q-Sub type.

Common Q-Sub types include Pre-Submission (the most-used type, sometimes called "Pre-Sub"), Submission Issue Request (for issues during active review), Study Risk Determination (to confirm SR vs NSR classification), Informational Meeting Request, and Agreement Meeting (for complex programs requiring binding scope agreement).

The written feedback FDA provides is non-binding but carries practical weight — FDA will reference prior Q-Sub agreements during review of the eventual 510(k) or PMA. Sponsors use Q-Subs to de-risk predicate selection, testing strategy, labeling claims, and clinical study design before significant investment.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside FDCA SECTION 513G, FDCA SECTION 515B.

FDA CDRHEMAHealth Canada

When This Matters

The team filed a Pre-Submission to obtain FDA feedback on the proposed predicate and bench testing plan before finalizing the 510(k).
A Study Risk Determination Q-Sub confirmed the clinical investigation qualified as non-significant risk.
FDA's Pre-Sub feedback reshaped the performance testing matrix and saved a likely Additional Information request post-filing.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

FDCA SECTION 513GFDCA SECTION 515B

How to File a Pre-Submission (Q-Sub) with FDA CDRH

File a Pre-Submission to obtain FDA feedback on your device development or submission plan before formal filing.

1
Scope the questions
Identify 3-5 specific, binary questions you need FDA feedback on — predicate selection, testing strategy, clinical study design, or labeling. Vague questions produce vague feedback.
2
Prepare the briefing document
Assemble a concise briefing document covering device description, intended use, proposed predicate (if 510(k)), testing plan, and the specific questions. Keep under 50 pages where possible.
3
Select Q-Sub type
Most sponsors file a Pre-Submission. Other types include Submission Issue Request, Study Risk Determination, Informational Meeting Request, and Agreement Meeting for complex programs.
4
Decide: written response only or meeting
Written feedback alone is faster (60-75 days). Requesting a meeting adds 2-3 weeks but enables real-time discussion of complex questions. Choose based on question complexity.
5
Submit via CDRH Portal
Submit the Q-Sub package through the CDRH Portal. No user fee applies. FDA acknowledges receipt and assigns a Q-Sub reference number.
6
Engage during review
If a meeting was requested, FDA schedules it 75-90 days after submission. Prepare to discuss specific questions, not re-present the briefing. Record outcomes for downstream referencing.
7
Document feedback for future filings
Capture FDA's written response verbatim. Link to relevant sections in your downstream 510(k), De Novo, or PMA so review teams can confirm alignment with prior Q-Sub agreements.

Frequently Asked Questions

No. Q-Sub feedback is advisory and non-binding, meaning FDA can reach a different conclusion during later review of the full submission. In practice, FDA reviewers reference prior Q-Sub agreements, so the feedback carries substantial practical weight.

Pre-Submissions typically receive a written response from FDA within 60-75 days. If a meeting is requested, it usually occurs 75-90 days after submission. Other Q-Sub types have their own timeframes published in FDA guidance.

No. Q-Submissions are not subject to MDUFA user fees. The 510(k) or PMA submission that follows a Q-Sub does incur the standard user fee at filing.