What Is an FDA Q-Sub Meeting vs. a Pre-Sub Meeting?
The FDA’s Q-Sub refers to the communication types available through this program, which includes:
- Pre-Submission (Pre-Sub) Meeting: Used to get FDA feedback on specific questions related to your regulatory strategy for a submission.
- Informational Meeting: Used to share new technology or data with FDA without expecting feedback.
- Study Risk Determination (SRD): Used to determine whether a planned clinical study carries significant or non-significant risk.
- Submission Issue Request (SIR): Used to resolve outstanding issues in submissions already under review or on hold.
The most common type of Q-sub meeting is the Pre-Sub meeting. This process allows medical device manufacturers to request written and in-person feedback from the FDA before submitting a 510(k), De Novo, Pre-Market Approval (PMA), Investigational Device Exemption (IDE), or other regulatory application. There is no user fee for Pre-Submissions.
Pre-Sub meetings are voluntary. However, a well-planned Pre-Sub can shorten your overall time to market. With advanced FDA input, you can avoid regulatory hurdles like Additional Information (AI) letters that may delay or stop your regulatory approvals, choosing the wrong predicate or pathway, or spending time and money on insufficient testing, where FDA expects you to include new device parameters or to add specific patients or user groups you didn’t plan to test.
What Is Included in an FDA Pre-Sub Meeting and When to Use It
A Pre-Sub meeting gives you a chance to present your regulatory strategy, device description, testing plans, or clinical protocols, and receive written feedback or meet with FDA reviewers. You can use a Pre-Sub to get input on:
- Regulatory pathway (510(k), De Novo, PMA, etc.)
- Predicate selection and discussion on equivalence
- Non-clinical and clinical testing strategy
- Biocompatibility, software validation, or usability plans
- Other specific concerns about your submission package
A Pre-Sub is most useful once you have a clear device concept, intended use, and early medical device technical documentation, but before you’ve committed significant resources to performance testing or clinical investigations. Many companies engage the FDA during the late design phase or pre-clinical stage, when they can still adapt their testing strategy based on FDA feedback. It’s also beneficial after benchmark testing, but before launching full verification and validation testing. For novel devices or uncertain classifications, you should engage with FDA as early as possible.
Examples of when to use a Pre-Sub:
- Feedback on your software validation plan for a wearable sensor with a novel algorithm.
- Input on your proposed clinical endpoints before designing your clinical investigation for a De Novo submission.
- Confirmation that biocompatibility testing will meet FDA expectations for a device using a new material.
What’s the Difference Between an FDA Pre-Sub Meeting and a 513(g) Request for Information?
Pre-Sub meetings and 513(g) requests serve different purposes and follow different processes. A 513(g) request is used to formally ask the FDA how your device is classified and results in a written, non-binding classification decision. This process does not involve a meeting, and you won’t receive feedback on testing, clinical data, or submission strategy. Unlike the Q-Sub program, the FDA also charges a user fee for 513(g) requests and will not begin processing the request until the fee is paid.
Many companies use both programs at different points in the regulatory process. You might begin with a 513(g) to confirm classification, then follow up with a Pre-Sub once your regulatory pathway is clear and you're ready to refine your submission plan.
In short:
- Use a 513(g) when you need to confirm your device’s classification or determine which regulatory pathway applies.
- Use a Pre-Sub when you know your device’s classification and need input on how to prepare a successful submission.
How to Request a Pre-Sub or Q-Sub Meeting with the FDA
FDA is moving all submissions to the Electronic Submission Template (eSTAR) portal, including Q-Sub requests. “Electronic Submission Template for Medical Device Q-Submissions” is the FDA guidance that contains draft recommendations for how to submit your Q-Sub request. The request must follow the format outlined in the FDA Q-sub meeting guidance document, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.”
After submitting your request, the FDA typically responds within 15 days to confirm receipt and determine if your request is accepted. If a meeting is requested, the FDA will usually schedule it within 75 days of receiving your request. FDA may refuse to accept a Q-Sub if it's missing key information, if questions are too vague or broad, or if the questions are outside the scope of the Q-Sub program.
How to Prepare for an FDA Pre-Sub or Q-Sub Meeting
A clear, organized Q-Sub package improves the quality of FDA feedback and saves time during review. Your request should include:
- A detailed cover letter identifying the type of Q-Sub meeting
- A clear device description, including intended use and technological characteristics
- A list of specific, numbered questions (usually 3-5)
- Supporting documentation such as design files, test plans for performance testing, including a list of US recognized standards applied, or clinical investigation protocols
- Regulatory history of the device and current performance testing status (overview)
- Preferred meeting format (written feedback only, web/teleconference, or in-person meeting with FDA)
Your FDA Q-sub meeting questions should be focused, relevant, and structured to help the FDA provide actionable input. Even if a live meeting is held, written feedback is typically provided three days before a scheduled meeting and serves as the primary record of the FDA’s response. The FDA Pre-Sub or Q-Sub Meeting usually is limited to 60 minutes, and this includes a summary of discussed elements at the end. Therefore, it is important to prepare well-structured information and focus on key questions first to maximize the limited meeting time.
Note that you need to submit the discussed items of the FDA Pre-Sub or Q-Sub Meeting to FDA. This is usually a protocol with detailed discussions, which will be reviewed by FDA for adequacy and then released, sent back and documented as a “Q”-document. In future submissions you need to reference these Q-documents and FDA may come back to the discussed items.
