adb-logo
Leveraging FDA Pre-Submissions to Guide Your Device Strategy

Using Pre-Subs to Shape Regulatory Pathways

The FDA Pre-Submission (Pre-Sub) program lets you ask targeted questions and gain early feedback on pathways, testing, or trials. Engaging FDA early reduces risk, refines your regulatory strategy, and strengthens confidence in your device development plan.

Frame-5

← Back to Regulatory Strategy Development

The Pre-Submission (Pre-Sub) process is a formal opportunity to ask FDA questions before you submit your application. Part of FDA’s Q-Submission program, a Pre-Sub allows you to get feedback on your device development plans early. By leveraging Pre-Subs, you can shape your regulatory strategy with FDA’s input – avoiding costly wrong turns or last-minute surprises. 

What is a Pre-Submission?

A Pre-Submission is a request to meet with or receive written feedback from FDA regarding a planned submission or device development question. You can discuss nearly any aspect of your device’s regulatory pathway. According to FDA guidance, Q-Sub interactions can include feedback related to IDE applications, PMA applications, HDE applications, De Novo requests, 510(k) submissions, and more. Essentially, if you have uncertainties – be it about the appropriate pathway, necessary testing, or clinical study design – the Pre-Sub process lets you consult FDA in advance. 

FDA encourages sponsors to take advantage of this program. It’s free and typically results in written feedback or a meeting within ~60–75 days. The feedback is non-binding (FDA isn’t making final decisions), but it is invaluable guidance. Think of it as getting a glimpse of the reviewer’s expectations while you still have time to act on it. 

pre-sub
when

When and Why to Use a Pre-Sub

Not every project needs a Pre-Sub, but strongly consider one if:

  • Regulatory Pathway Unclear:
    If you are debating 510(k) vs De Novo vs PMA, ask FDA. You can present your device and its predicate (if any) and ask, “Does FDA agree with our proposed pathway (e.g. 510(k) vs De Novo)?” Getting confirmation in a Pre-Sub can save you from pursuing the wrong route for months.
  • Novel Technology or Indications:
    If your device uses new technology or a technology used in a new way, there may be no clear testing guidelines. In a Pre-Sub, you can outline your proposed testing plan and ask if it’s adequate. FDA may suggest additional tests or different endpoints. It’s far better to learn these expectations in advance than via a deficiency letter after submission.
  • First-Time or Small Companies:
    If you’re new to the FDA process, a Pre-Sub can serve as a check-in to ensure you haven’t overlooked anything major. Many startups use Pre-Subs to build a relationship with FDA project managers, discuss applicable guidance, and clarify any novel aspects of their device (e.g. unique software algorithms). Early dialogue builds trust and can prevent misunderstandings.

Crafting an Effective Pre-Submission

Success with Pre-Subs hinges on asking the right questions and providing the right background:

  • Be Specific:
    Frame 3–5 precise questions that you need answers to. For example: “Does FDA concur that our device can be considered substantially equivalent to the cited predicate?” or “Are the planned biocompatibility tests sufficient for the new coating material?” Avoid vague queries – make them direct and answerable.
  • Provide Context:
    Give FDA enough context to understand your device and questions. Include pertinent summaries (e.g. an outline of your test plan or a clinical protocol synopsis) so reviewers can provide actionable feedback. Clear, well-organized background info leads to more useful answers.
  • Document FDA’s Feedback:
    FDA’s responses aren’t official approvals, but treat them as strong guidance. Document the feedback and how you will address it. In your eventual submission, you can even mention how you adjusted your plans in response to the Pre-Sub – showing FDA you took their advice builds reviewer confidence.
effective

From Pre-Sub to Submission – Staying Agile

The real benefit of a Pre-Sub is realized in how you act on the feedback. Revise your development and testing plans based on FDA’s input – perhaps running an extra validation, modifying an endpoint, or choosing a different predicate as recommended. Update your regulatory strategy to document what FDA advised and how you adjusted. This shows the FDA you took their input seriously and helps keep your team aligned. If new questions arise or your plan changes significantly, you can always request a follow-up Pre-Sub. Using Pre-Subs judiciously throughout development fosters a collaborative relationship with FDA and sets a positive tone for your eventual submission review.

staying-agile

Conclusion

The Pre-Submission process is one of the most powerful (and underutilized) tools in medical device development. It’s like having a roadmap where some of the twists and turns are labeled in advance by the very entity that will evaluate your device. By engaging in Pre-Subs, you de-risk your regulatory journey – making informed decisions backed by FDA’s perspective. In a landscape where unknowns equal risk, Pre-Subs turn many unknowns into knowns. ADBC CRO routinely helps clients prepare effective Pre-Submission packages and meetings, ensuring you ask the right questions and get meaningful answers. By the time you file your 510(k), De Novo, or PMA, you’ll do so with confidence that you’re meeting FDA’s expectations head-on, thanks to groundwork laid with Pre-Subs. 

Contact us to Leverage Pre-Subs in Your FDA Strategy

Contact Now
0 +

Customer Served

0 +

Product Launched

0 +

Regulatory Submissions