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FDA’s Pre-Submission Program for a Stronger IDE

Using FDA’s Pre-Submission Program to Improve Your IDE Submission

Learn how engaging FDA early via the Pre-Submission (Pre-Sub) program can de-risk your IDE submission. Get feedback on study design, preclinical testing, and regulatory expectations to improve approval chances and streamline your device trial planning.

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A smart way to de-risk your IDE submission is to engage with the FDA early through the Pre-Submission (Pre-Sub) process. The Pre-Submission is part of FDA’s Q-Submission program that allows sponsors to obtain feedback from FDA on planned submissions, including IDEs, before officially filing them. This can be invaluable for startups and new sponsors unfamiliar with FDA expectations. Here’s how to leverage pre-subs for IDEs: 

Why Use a Pre-Submission for an IDE?

FDA “encourages” sponsors to contact them prior to IDE submission, especially if you’re a first-time sponsor or you’re working with a novel technology. Early interaction can:

  • Clarify FDA’s requirements and guidance relevant to your device and trial, so you can design a better study.
  • Allow FDA reviewers to familiarize themselves with your technology ahead of the actual IDE, potentially speeding up the review.
  • Identify any red flags in your plan (e.g., insufficient preclinical testing or a high-risk protocol design) while there’s still time to fix them, thus avoiding an IDE disapproval or costly amendments later.
  • Overall, it can “speed the regulatory process and minimize delays” by resolving questions early.
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Types of Q-Subs for IDE Planning

There are two main Q-Submission tools relevant to IDEs: 

1. Pre-Submission Meetings (Pre-Subs): 

You submit a briefing document and list of questions to FDA, and FDA provides written feedback and optionally a meeting (teleconference or in-person) to discuss. For IDEs, common Pre-Sub questions might include:

  • Is our planned trial design (endpoints, sample size, follow-up duration) adequate to support a future marketing application?
  • Are our proposed preclinical tests sufficient, or does FDA recommend additional testing before IDE?
  • Feedback on elements of the investigational plan (e.g., inclusion/exclusion criteria, safety monitoring plan).
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  • Clarification on regulatory pathways: for example, confirm that the study indeed requires an IDE and not some other mechanism. FDA’s goal is to send written feedback on Pre-Subs within 70 days of submission, or at least 5 days before a scheduled meeting. This timeline is longer than the IDE review, so plan your Pre-Sub well in advance of the IDE target date. There is no fee, and sponsors often find FDA’s input extremely helpful.

2. Study Risk Determination (SRD) Q-Sub: 

As mentioned in the risk section, you can specifically ask FDA to confirm whether your study is SR, NSR, or exempt. This is usually a shorter submission focusing on device description and protocol synopsis. FDA will issue a letter with their official determination. Use this if there’s ambiguity or disagreement about the need for an IDE. Note that an SRD Q-Sub typically does not involve a meeting; FDA will just provide the written determination.

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Effective Pre-Sub Preparation

To get the most out of a Pre-Submission:

  • Do your homework first:
    Review FDA’s guidance documents on your device type and clinical trial design. The better-informed your questions, the more useful FDA’s answers. For example, if FDA has a guidance on trials for orthopedic implants or diagnostics, incorporate those recommendations and ask if your plan aligns.
  • Ask clear, specific questions:
    For instance, instead of asking “Is our protocol okay?”, detail the key aspects and ask about specific potential issues (e.g., “Is a 6-month follow-up adequate to capture safety endpoints for this device?”).
  • Provide context in the briefing package:
    Include a concise device description, summary of prior testing, and an outline of the proposed study. FDA reviewers can give more targeted advice when they understand the technology and rationale.
  • Use it as a dialogue:
    If you have a meeting, treat it as a chance to brainstorm solutions. FDA may raise concerns – use the time to ask how those concerns could be mitigated. Take good meeting minutes (and send them to FDA for concurrence if it was a formal meeting).
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Benefits of Pre-Sub Feedback

Any feedback you receive from FDA in a Pre-Sub is non-binding, meaning it’s not an official approval. However, it’s given in good faith – if you follow FDA’s recommendations, you’re more likely to have a successful IDE. For example:

  • If FDA indicated that a certain safety test should be completed pre-IDE, and you do it and include results, your IDE review should go more smoothly on that point.
  • If FDA agreed that your primary endpoint is acceptable, they are unlikely to object to it during IDE or PMA review unless new information emerges.
  • Should there be a change in perspective, FDA tries to inform you, but generally Pre-Sub advice is a strong hint of what will be expected.
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Timing and Logistics

Plan to submit a Pre-Sub 3-4 months before you aim to submit the IDE. This gives time for FDA’s response and for you to integrate their feedback. Remember that while waiting for Pre-Sub feedback, you can be finalizing other aspects of your IDE package. If your timeline is very tight, you could proceed without a Pre-Sub, but that carries risk. Many experienced sponsors consider the Pre-Sub a standard part of the IDE development timeline because it ultimately saves time by avoiding trial-and-error in the IDE submission.

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Beyond Pre-IDE: Continuous FDA Interaction

Even after an IDE is approved, you can use the Q-Submission program for further feedback. For example, if after some study data accrues you want FDA’s thoughts on modifications or on the subsequent PMA, you can do another Pre-Sub. FDA also offers more formal Early Collaboration Meetings (Determination and Agreement meetings) for pivotal study plans, though those are more often used for PMA discussions. 

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In summary, don’t go it alone – engaging FDA early through Pre-Subs is a wise strategy, particularly for startups who may not have prior FDA experience. It turns a potentially one-sided IDE submission into a two-way conversation with regulators, which can greatly improve the quality and acceptability of your investigational plan. As FDA itself notes, increased interaction can “speed the regulatory process and minimize delays in development of useful devices”. 

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