FDA Pre-Submission (Q-Sub) Consulting — Flat-Fee

Published Pricing

One Package. One Price. No Hourly Billing.

The Pre-Sub package is flat-fee and published. Everything needed to prepare, refine, and submit your Q-Sub to FDA is included.

Flat-Fee

Pre-Sub Strategy & Briefing Package

$6,500

flat fee · all-in · no hourly billing

Regulatory strategy session and pathway review
Complete Pre-Sub briefing document drafted to FDA’s Q-Submission guidance format
Question strategy: 3–5 specific, answerable questions engineered for actionable feedback
Device description, proposed indications, and testing-plan sections reviewed and assembled
eSTAR/CCP submission of the Q-Sub package to FDA
One revision round based on your team’s review

FDA’s response, timing, and conclusions are FDA’s alone — the briefing package addresses what is within your control.

Additional Pre-Sub Services

Scoped per engagement — quoted after the initial session.

Mock FDA meeting facilitation
Structured rehearsal with ADB in the FDA reviewer role — surfaces weak questions and answer gaps before the actual meeting.
Discuss your situation →
Meeting attendance and minutes
ADB attends the FDA meeting with your team, takes contemporaneous notes, and delivers a structured minutes document for your regulatory file.
Discuss your situation →
Post-meeting strategy memo
Written summary of FDA’s responses with an updated regulatory strategy and revised testing plan aligned to FDA’s feedback.
Discuss your situation →
Follow-on submission support
510(k), De Novo, or PMA preparation following the Pre-Sub outcome — scoped after FDA’s written response is received.
Discuss your situation →

These services are quoted individually after the initial strategy session, when the scope is defined. No dollar amounts are published here because the right scope depends on your specific situation.

FDA Meeting Preparation

How to Prepare an FDA Meeting Package That Maximizes Useful Feedback

The difference between a productive Pre-Sub and a non-committal FDA response is almost always the briefing package. These four principles determine how useful FDA’s written feedback will be.

Ask specific, answerable questions — not open-ended ones

FDA cannot answer “What does FDA think about our 510(k) strategy?” — that is not a question, it is an invitation for a general response. Effective questions are anchored to a specific proposed approach: “Does FDA agree that our proposed bench-testing protocol for [specific characteristic] is sufficient to support substantial equivalence?” A yes or a conditional yes from FDA on that question has regulatory value. A general response does not.

Give FDA a complete picture of the device and testing plan

FDA’s feedback is only as good as the information in the briefing document. A vague device description and a sketched testing plan produce hedged FDA responses. A complete briefing — with specific indications, detailed device description, and a proposed testing approach for FDA to react to — produces specific, documented FDA guidance. Incomplete packages are the primary cause of non-committal Pre-Sub responses.

Propose your position and ask FDA to react to it

The most effective Pre-Sub questions follow a specific structure: state your proposed approach, provide the regulatory rationale, and ask FDA whether they agree or have concerns. This format gives FDA something concrete to respond to and almost always produces more specific feedback than open questions. It also creates a written record of your regulatory reasoning that carries weight in the actual submission.

Time the Pre-Sub before you spend on testing, not after

A Pre-Sub is most valuable before you design the testing program — when FDA’s input can change what you test and how. After testing is complete, a Pre-Sub can still confirm that your data package is sufficient, but it cannot undo a testing program designed around the wrong standard or acceptance criteria. The 70–75 day FDA response window is worth it when the alternative is repeating expensive testing.

The Q-Sub Process

How the Q-Submission Process Works

The Q-Sub process follows a defined FDA timeline. Understanding the sequence helps you plan your development program around the feedback window.

Q-Sub package submitted to FDA
The complete Pre-Sub package — cover letter, device description, indications, testing summary, and specific questions — is submitted via eSTAR or the Correspondence and Communication Portal (CCP).
FDA acknowledgment
FDA issues an acknowledgment letter within approximately 14 days confirming receipt. For meeting requests, the letter confirms the meeting date. For written-response-only requests, it confirms FDA will provide written feedback.
Written feedback and/or meeting
FDA provides written feedback, typically within 70–75 days of receipt. If a meeting was requested, FDA holds the meeting within this window and follows up with written minutes. FDA’s responses to your specific questions are documented in the meeting minutes or feedback letter.
Meeting minutes and post-meeting strategy
FDA issues official meeting minutes within approximately 30 days of the meeting. These minutes are part of your regulatory file and can be cited in subsequent submissions. A post-meeting strategy memo from ADB translates FDA’s responses into an updated development and testing plan.

Common Questions

Frequently Asked Questions

What is an FDA Pre-Submission (Q-Sub)?

A Pre-Submission (Q-Sub) is a formal FDA feedback mechanism that allows sponsors and applicants to submit specific questions to FDA before filing a premarket submission. FDA reviews the briefing document and either provides written feedback alone or holds a meeting. The process is governed by FDA’s Q-Submission Program guidance and is available for 510(k), De Novo, PMA, SaMD, and IDE submissions, among others.

How do I prepare an FDA Pre-Sub meeting package?

A Pre-Sub package must include a cover page identifying the submission type, a device description with intended use, a proposed testing plan or data summary, and specific questions for FDA. The questions are the most important element — each question should be specific and answerable, with a proposed position for FDA to react to. Vague or open-ended questions produce vague FDA responses. ADB prepares the briefing document and question strategy to FDA’s Q-Submission guidance format.

How long does FDA take to respond to a Pre-Sub?

FDA’s target response time for a Pre-Sub is approximately 70 days from the date FDA acknowledges receipt of the Q-Sub. FDA first issues an acknowledgment letter within about 14 days confirming receipt. For meeting requests, FDA typically holds the meeting within 70–75 days of receipt. Written-response-only Q-Subs generally receive feedback within the same window. These are FDA targets — actual timelines vary by device type and meeting type.

What questions should I ask FDA in a Pre-Sub?

Effective Pre-Sub questions are specific and anchored to your proposed testing approach or regulatory strategy. Examples: “Is our proposed bench-testing protocol sufficient to support substantial equivalence for [specific performance characteristic]?” or “Does FDA agree that our proposed software testing and lifecycle approach meets the expectations in FDA’s Software as a Medical Device guidance?” Avoid open-ended questions like “What does FDA think about our device?” — those produce non-committal responses.

Is FDA’s Pre-Sub feedback binding?

No. Pre-Sub feedback is nonbinding — FDA can and does update its position during substantive review of a full submission. However, the written feedback is documented in your submission file, and FDA reviewers take it seriously. Following FDA’s Pre-Sub guidance significantly reduces the risk of an Additional Information (AI) request or Refuse to Accept (RTA) finding during the actual review. Pre-Sub feedback is one of the most reliable ways to de-risk a submission strategy before committing to a testing program.

FDA Pre-Submission (Q-Sub) Consulting — Flat-Fee Meeting Packages