What if you could sit down with the FDA and ask, “Are we on the right track?” before you submit your application?

No second-guessing. No waiting months for an answer you could have predicted. Just direct, actionable feedback that saves you time, money, and frustration.

That’s the power of the FDA Q-Submission program — but only if you use it.

Many companies don’t. Either they don’t know the program exists, or they assume they can navigate the regulatory process without it. Then, months down the road, they find themselves stuck in a cycle of back-and-forth questions, unexpected deficiencies, and costly delays that could have been avoided.

The FDA Q-Submission program is designed to give medical device companies a direct line to the FDA before they submit their official application. Whether you’re pursuing a 510(k), De Novo, or PMA submission, this program can help you gain clarity on testing requirements, study designs, and overall regulatory expectations—all before you lock in your strategy.

So, how does it work? And more importantly, how can you leverage it to streamline your regulatory pathway? 

What is the FDA Q-Submission Program?

The FDA Q-Submission program is a voluntary process that allows medical device companies to get feedback from the FDA before formally submitting an application. Think of it as a way to test the waters and identify potential issues early, rather than finding out too late that your submission has gaps.

This program is particularly valuable for companies developing new or complex medical devices, as it helps clarify regulatory expectations upfront. Instead of making assumptions about what the FDA wants, you can ask directly and adjust your strategy accordingly.

By participating in the FDA Q-Submission program, companies can:

• Gain insight into FDA expectations for their specific device and regulatory pathway.
• Identify potential deficiencies before submitting a 510(k), De Novo, or PMA.
• Reduce the risk of delays caused by missing or unclear information.

In short, the FDA Q-Submission program is a tool to help companies navigate the regulatory process with fewer surprises. But why does it matter so much? Let’s dive into the key benefits.

Why Does the FDA Q-Submission Program Matter?

Regulatory uncertainty is one of the biggest roadblocks for medical device companies. Misinterpret a requirement, and you could face months of delays—or worse, outright rejection. The FDA Q-Submission program is designed to prevent that.

Here’s why it matters:

• It speeds up approvals. By addressing FDA concerns early, you reduce the likelihood of major surprises or deficiencies in your submission.
• It de-risks the process. Instead of guessing what the FDA wants, you get direct insights, minimizing the chances of costly rework.
• It improves your strategy. The FDA’s feedback can help refine your clinical study plans, testing requirements, and overall regulatory approach.

Skipping this step means flying blind—something no medical device company can afford. Taking advantage of the Q-Submission program ensures you’re on solid ground before moving forward.

Next, let’s explore the different types of Q-Submissions and how to choose the right one for your needs.

Types of Q-Submissions

Not all Q-Submissions are the same. The FDA offers different types of Q-Submissions depending on what kind of feedback you need. Choosing the right one ensures you get the most relevant guidance for your regulatory strategy.

Here are the main types:

• Pre-Submission (Pre-Sub) – This is the most common type of Q-Submission. It allows you to seek FDA feedback before submitting a 510(k), De Novo, or PMA application. Companies use Pre-Subs to clarify regulatory requirements, validate their testing plans, and ensure their clinical study design aligns with FDA expectations. The earlier you get feedback, the better positioned you’ll be to submit a strong application.
• Submission Issue Request (SIR) – Sometimes, questions or concerns arise while the FDA is actively reviewing your submission. Instead of waiting for an official deficiency letter, an SIR lets you proactively engage with the FDA to resolve issues quickly. This can prevent unnecessary delays and keep your submission moving forward.
• Study Risk Determination – If your device requires a clinical study, the FDA classifies it as either a Significant Risk (SR) or Non-Significant Risk (NSR) study. Getting this determination in advance helps you understand what level of regulatory oversight your study will require, including whether you need an Investigational Device Exemption (IDE) before proceeding.
• Informational Meeting – Sometimes, companies need to engage with the FDA for general discussions that aren’t tied to a specific submission. Informational meetings provide an opportunity to introduce new technologies, discuss regulatory strategies, or seek clarification on policies without expecting formal feedback. These meetings can be valuable for long-term planning and alignment with the FDA.

Each type serves a unique purpose. The key is understanding which one fits your needs at the right stage of your submission process.

Next, let’s walk through how to prepare a strong Q-Submission request to maximize your chances of receiving useful feedback.

How to Prepare a Strong Q-Submission

A well-prepared Q-Submission can mean the difference between receiving clear, actionable feedback or vague, noncommittal responses from the FDA. To maximize the value of this process, here’s how to ensure your submission is effective:

• Clearly define your questions. The more specific your questions, the more useful the FDA’s feedback will be. Avoid broad or overly general inquiries—focus on key regulatory uncertainties, testing strategies, or study design concerns.
• Provide enough background—but keep it focused. The FDA needs sufficient context to provide meaningful guidance, but too much information can bury the key issues. Include a concise summary of your device, intended use, and relevant supporting data without overwhelming the reviewers.
• Be strategic with timing. Submit your Q-Sub early enough to influence your development strategy but not so early that you lack key details the FDA needs to provide meaningful feedback. Finding the right balance ensures their guidance is actionable.
• Engage the right experts. Bring your regulatory, clinical, and technical teams into the process. Having cross-functional expertise ensures that the questions you ask—and the feedback you receive—align with both regulatory and technical considerations.

Taking the time to craft a strong Q-Submission increases your chances of receiving valuable, decision-enabling guidance. Next, let’s look at what to expect from the FDA once you’ve submitted your request.

What to Expect from the FDA

Once you submit your Q-Submission, what happens next? Understanding the FDA’s process and timelines can help you plan accordingly and make the most of the feedback you receive.

• Typical Response Time: The FDA generally responds within 70 calendar days of receiving your request. However, timelines can vary depending on the complexity of your submission and the agency’s workload.
• Meeting vs. Written Feedback: Depending on your request, the FDA may provide feedback in one of two ways:
  • A written response with detailed answers to your questions.
  • A meeting (in-person or virtual) where you can discuss their feedback in real-time. Meetings often allow for clarification and follow-up questions, making them particularly useful for complex submissions.
• The Importance of Meeting Minutes: If you have a meeting, you’ll receive official written minutes summarizing the FDA’s feedback. Treat these like gold—this documentation can guide your regulatory strategy and ensure alignment with FDA expectations.
• Non-Binding but Insightful: While Q-Submission feedback isn’t legally binding, it provides strong indications of what the FDA will expect in your formal submission. Companies that act on this guidance often have smoother approval processes with fewer surprises.

By understanding what to expect, you can better prepare for the next steps and ensure you’re using the FDA’s feedback to strengthen your submission.

Next, let’s wrap up with key takeaways on when a Q-Submission is the right move for your company.

Key Takeaways: Is a Q-Submission Right for You?

Not every medical device company takes advantage of the Q-Submission program—but should you? If you’re on the fence, here are some clear indicators that a Q-Submission could be a smart move for your regulatory strategy.

A Q-Submission is likely right for you if:

• You’re unsure about your regulatory pathway and need clarity on whether to pursue a 510(k), De Novo, or PMA submission.
• You need FDA input on your clinical study design to confirm your approach before investing time and resources.
• You’re introducing a novel technology and want to align expectations with the FDA early.
• You’re concerned about testing requirements and need guidance on what data the FDA will expect.

Skipping the Q-Submission? You might be setting yourself up for:

• Expensive delays due to unexpected deficiencies in your submission.
• Avoidable back-and-forth with the FDA that could have been addressed earlier.
• Unnecessary risk if your assumptions about testing or study requirements turn out to be incorrect.

A Q-Submission is an opportunity to de-risk your process, clarify expectations, and prevent costly surprises. If your submission involves any uncertainty, it’s worth considering.

Next, let’s talk about how expert guidance can make the process even smoother.

Final Thoughts: Get Expert Help for your FDA Q-Submission program Submission

The FDA Q-Submission program can be a game-changer—if you use it wisely. It’s not just about getting feedback; it’s about asking the right questions, providing the right context, and using the insights to strengthen your submission.

But navigating this process effectively takes experience. A poorly structured Q-Submission can result in vague or unhelpful feedback, leaving you just as uncertain as before. That’s where expert guidance can make all the difference.

At Fission Consulting, we help medical device companies craft strong Q-Submissions that lead to clear, actionable FDA feedback. Our team ensures you ask the right questions, present the right data, and walk away with insights that truly move your submission forward.

Need guidance on your Q-Submission? Let’s talk. Reach out today to ensure you’re making the most of this critical FDA program.