RECORDREFERENCE OUTLINE

Q-Submission (Pre-Sub) Request

Pre-Submission request built on the content FDA recommends in its Q-Submission Program guidance: readiness checks, cover letter, meeting request, purpose, device description, proposed indications for use, regulatory history, planned follow-on submission, background tied to questions, and specific questions framed as proposals within FDA's topic and question limits. Includes the feedback timeline and a meeting-minutes outline.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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HOW TO FILL THIS IN
How to Choose a US Device Premarket Pathway, step by step →
REGULATIONS MAPPED
FDA Q-Submission Program Guidance (2025)
DOCUMENT TYPE
Record
LAST UPDATED
October 2026
PURPOSE

A Pre-Submission request structured to the content FDA recommends, so a founder asks questions FDA can answer and gets feedback that changes what they do next. A Pre-Sub is the cheapest regulatory advice available and the most commonly wasted: its value is set by the package and by whether each question presents a proposal specific enough to agree or disagree with.

What's Inside

✓Readiness checks, including when a question belongs in a 513(g) request instead
✓Cover letter fields, feedback method, and a meeting request with agenda, format, dates and attendees
✓Purpose, device description and proposed indications for use or intended use
✓Regulatory history and the planned follow-on submission
✓Background information tied to the questions it supports
✓Specific questions framed as proposals with rationale, within FDA's recommended topic and question limits
✓The feedback and minutes timeline, and a meeting-minutes outline following the guidance's optional example

How to Use It

1Settle the indications for use and the planned pathway before asking about testing; FDA notes that testing feedback depends on both
2Choose no more than three to four substantial topics and about seven to ten questions in total
3For each question, write your proposal and its rationale first, then ask whether FDA agrees
4Remove questions that ask about the final outcome, ask FDA to design a study, or ask for a classification determination
5Attach only background that a question needs, and say which question it supports
6Plan to submit draft minutes within 15 days of a meeting, and reference this Q-Sub in every related later submission
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Before You Submit
2Cover Letter
3Meeting Request
› Draft agenda
4Purpose
5Device Description
6Proposed Indications for Use or Intended Use
7Regulatory History
8Planned Follow-On Submission
9Background Information
10Specific Questions
11After Feedback
AAppendix A — Meeting Minutes Outline
BAppendix B — Approval
REGULATORY CONTEXT

The template follows the FDA guidance "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program", issued by CDRH and CBER on 29 May 2025, which supersedes the June 2023 version. The guidance is nonbinding and the Q-Sub program is voluntary. Its recommended Pre-Sub content, the limits of three to four substantial topics and seven to ten questions, the 70-day written feedback timeline and the 15-day meeting minutes timeline are taken from that document. FDA feedback is advice on the information provided, not a decision. Whether to request a Pre-Sub, and what to ask, are your determinations.

MAPPED STANDARDS
FDA Q-Submission Program Guidance (2025)
Browse the standards catalog →

WHERE NEXT

  1. FILL IT INHow to Choose a US Device Premarket Pathway →The procedure this template records, one step at a time.
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