US · FDA Q-Submission / Pre-Sub · IDE · 510(k) · De Novo · PMA
FDA Q-Submission (Pre-Submission) Strategy & Package
We build a complete Q-Submission (Pre-Sub) package so you can obtain formal, nonbinding FDA feedback before you file an IDE, 510(k), De Novo, or PMA. We help you frame focused questions, provide the right context and evidence, propose meeting dates 60–75 days out, and prepare the file to pass the 14-day acceptance screen—submitted as an eCopy via the CDRH Portal.
De-risked plan
Reviewer-friendly questions
On-time acceptance
Meeting-ready
Why a Q-Submission Matters Before You File
A Q-Submission (Pre-Sub) is FDA’s mechanism to give you structured, written feedback—and optionally a 1-hour meeting—before you commit to a major submission.
- Time & risk: Formal, nonbinding feedback helps confirm study designs, endpoints, performance benchmarks, and regulatory strategy before you invest in costly testing or multi-year trials.
- Timing expectations: Program materials indicate that FDA typically provides written feedback around day ~70, with meetings commonly targeted around days 70–75 after receipt (you propose dates with the Q-Sub).
- Intake requirements: Many Q-Subs undergo a 14-day acceptance review; if basics are missing, scheduling and feedback are delayed.
- Submission format: Q-Subs are submitted as an eCopy via the CDRH Portal. FDA has proposed PreSTAR—an electronic template for Pre-Subs—intended to streamline content in the future.
Used well, a Q-Sub turns assumptions into documented FDA advice instead of guesswork.
Who This Service Is For
We support teams who want focused FDA input, not generic templates.
- RA/QA owners responsible for IDE, 510(k), De Novo, or PMA strategy.
- Clinical and statistics leads aligning endpoints, analysis plans, and sample sizes with reviewer expectations.
- Engineering and cybersecurity/human factors teams seeking feedback on performance benchmarks and mitigation approaches.
- Project leaders preparing first-in-kind or novel technologies who want FDA to react before locking designs and protocols.
- Typical triggers:
- No clarity on whether 510(k), De Novo, or PMA is the right route.
- Need FDA views on pivotal study design, endpoints, or control group.
- Novel performance, cybersecurity, or usability approach that goes beyond standard guidance.
- First-time use of Q-Submission or limited prior direct FDA interaction.
What You Will Receive
The service is built around one goal: a focused, acceptance-ready Q-Submission that asks the right questions and prepares you for day-70 feedback and the optional 1-hour meeting.
Q-Sub Brief
- Objective of the interaction (what decisions you want to inform).
- Device overview, indications for use, and high-level regulatory context.
- Summary of where you are in development and what submissions you plan (IDE, 510(k), De Novo, PMA).
Precisely Framed Questions With Proposed Positions
- Clear questions grouped by topic (e.g., study design, endpoints, comparators, performance benchmarks, cybersecurity/usability, regulatory pathway).
- Concise context for each question so reviewers see the problem you are solving.
- Clear questions grouped by topic (e.g., study design, endpoints, comparators, performance benchmarks, cybersecurity/usability, regulatory pathway).
Evidence Snapshots Tied to Each Question
- One- to two-page summaries or tables of data relevant to each question (bench, modeling, early clinical, risk analysis).
- Pointers to underlying reports, protocols, or standards where the reviewer can find details.
Meeting Request Pack
- Written feedback-only option or written feedback + 1-hour meeting, as appropriate.
- Three or more proposed meeting dates 60–75 days after FDA receipt.
- Draft agenda and proposed attendees with roles (who will cover which topics).
Acceptance-Screen Checklist (14-Day Intake)
- Checklist of key administrative and content items required for the 14-day acceptance screen.
- Cross-reference to where each item appears in the Q-Sub package.
- Notes on common refusal-to-accept issues and how they were addressed in your file.
Rehearsal & Notes
- Brief meeting rehearsal with talking tracks aligned to your questions and positions.
- Feedback capture template for the written response and the meeting.
- Action log to convert FDA feedback into protocol changes, design updates, or strategy decisions.
How Our Q-Submission Service Works
We turn scattered questions and documents into a focused Q-Sub package FDA can respond to.
Discovery
- Clarify the decisions you want FDA to inform (e.g., endpoints, comparators, pathway, test scope).
- Capture device description, indications/claims, current data, and timelines for the main submission.
Question Framing
- Draft precise questions, each with context and your proposed position.
- Group questions by theme and prioritize so FDA time is used where it matters most.
Build the Q-Sub Package
- Write a concise background narrative that sets up your questions without overwhelming reviewers.
- Assemble targeted attachments: evidence snapshots, draft study outlines, risk summaries.
- Propose three or more meeting dates 60–75 days out, plus agenda and attendee list.
- Format the Q-Sub for eCopy submission via the CDRH Portal (and align with PreSTAR where helpful as it is rolled out).
Acceptance & Feedback Preparation
- Run a 14-day acceptance-style pre-check to reduce intake delays.
- Provide a simple tracker aimed at day-70 written feedback and the optional 1-hour meeting.
- Prepare talking tracks and a capture template so you can turn FDA feedback into concrete changes.
What We Need From You
We keep your input focused on decisions and data, not formatting.
- Device description, intended use, and planned indications for use.
- Summary of prior regulatory interactions (if any) and intended submission type (IDE, 510(k), De Novo, PMA).
- Current nonclinical and clinical data (or plans) relevant to your key questions.
- Draft or outline of pivotal study designs, performance benchmarks, cybersecurity/usability concepts, or other topics for feedback.
- Internal stakeholders and roles for the meeting (who owns clinical, statistics, engineering, regulatory).
- Target timing for receiving and applying FDA feedback.
Consulting and documentation only. We do not perform laboratory testing and do not author labels; you submit the Q-Submission via your regulatory owner or U.S. Agent.
FREQUENTLY ASKED QUESTIONS
How soon is FDA feedback after a Q-Submission?
Q-Subs are currently submitted as an eCopy via the CDRH Portal. FDA has proposed an electronic template called PreSTAR for Pre-Subs, which may be used voluntarily during a transition period.
No. Q-Submission feedback is nonbinding, but it is formal written advice that FDA expects you to consider and address when you later submit your IDE, 510(k), De Novo, or PMA.
Common topics include study design and endpoints, choice of control or comparator, performance test plans, predicate vs. De Novo path, cybersecurity and usability approaches, and classification questions for novel technologies.
No. A Q-Sub is a pre-submission mechanism. It does not authorize marketing and cannot substitute for an IDE, 510(k), De Novo, or PMA.
The formal submission is made by your regulatory owner or U.S. Agent. We prepare the content and structure and provide submission-ready files and instructions for them to use.
Use FDA’s Q-Submission Program to De-Risk Your Main Submission
A well-built Q-Submission replaces internal debate with formal FDA feedback—before you lock in your pivotal study or main submission plan. We help you crystallize the decisions you need FDA to react to, frame sharp questions with supporting evidence, build a Q-Sub package that passes the 14-day acceptance screen, and prepare your team for day-70 feedback and a focused 1-hour meeting.
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