The Harsh Reality of First Time FDA Submissions

Most first time FDA submissions don’t pass on the first try.
Not because the product isn’t ready, but because the strategy wasn’t.

That’s a tough pill to swallow, especially after months (or years) of development, testing, and planning. But it’s a reality too many startups face. They think they’ve done everything right. Then comes the dreaded “Additional Information Requested” letter…or worse, a flat-out Refuse to Accept (RTA).

And just like that, you’re stuck.

✅ Time lost.
💸 Cash burned.
😡 Frustrated team and investors.

All because your submission wasn’t built for how the FDA actually reviews it.

So why do so many submissions flop the first time? Allow us to shed some light on this.

Common Reasons First Time FDA Submissions Fail

You’d be surprised how often great products get delayed by simple, avoidable mistakes. It’s not usually about the technology, it’s about how the story is told to the FDA.

Here’s what we see trip up first-timers the most:

1. Rushing the Process
   You’ve got a deadline. The team’s feeling the pressure. So you push to “just get something in.” But speed without strategy is a gamble—and the FDA doesn’t reward rushed work. Skipping a pre-sub, glossing over key documentation, or submitting before you’re truly ready almost always backfires.
   
2. Incomplete or Disorganized Documentation
   Imagine being the reviewer. You open the file and… it’s chaos. Missing test reports, inconsistent labeling, confusing formatting. Even if the content is technically correct, if it’s hard to follow, you’re making the reviewer’s job harder and increasing the chance of an RTA.
   
3. Weak or Misaligned Predicate Devices (for 510(k))
   This one’s sneaky. You pick a predicate that seems close enough. But “close” doesn’t cut it. If the predicate doesn’t clearly match your device’s intended use or tech specs, expect questions or a rejection.
   
4. Inadequate Risk Management or Software Documentation
   This is where a lot of Software as a Medical Device (SaMD) submissions stumble. Weak traceability, unclear software classification, poor alignment with IEC 62304, or missing cybersecurity documentation? The FDA will flag it every time.
   
5. Assuming a One-Size-Fits-All Approach
   FDA submissions aren’t plug-and-play. What worked for a Class I device or a different product line won’t always work for yours. Treating the submission like a formality instead of a strategic communication tool is a fast track to a costly delay.

Each one of these issues is avoidable, but only if you know what to look for.

Now that you know what goes wrong, here’s how to get it right.

Lessons Learned: How to Avoid These Mistakes

Getting your FDA submission right the first time isn’t about being perfect. It’s about being prepared, strategic, and clear. Here’s how to stack the odds in your favor:

1. Start With a Pre-Sub, Seriously
   Think of it as free coaching. A pre-submission meeting gives you early feedback directly from the FDA, before your clock starts ticking. It also shows the agency you’re collaborative and serious. Skipping it to “save time” often does the opposite.
   
2. Use a Quality Submission Checklist
   You wouldn’t launch a product without a checklist, so don’t submit to the FDA without one either. Make sure every section is accounted for, every attachment is included, and everything is in the format they expect. Bonus tip: have someone outside your core team review it with fresh eyes.
   
3. Don’t DIY Without Support
   Sure, your team built the product, but that doesn’t mean you’re best equipped to explain it to the FDA. Whether it’s a regulatory consultant, a third-party reviewer, or someone who’s done this before, getting a second set of experienced eyes can save you from painful oversights.
   
4. Map Every Claim to Supporting Evidence
   If you say your device is safe, prove it. If you say it performs as intended, show the data. For every claim in your submission, there should be a test report, justification, or rationale to back it up. Make it easy for the reviewer to connect the dots.
   
5. Write for Your Audience: The FDA Reviewer
   You’re not writing a pitch deck, you’re building a case. Keep it simple, structured, and scannable. Include rationales where needed. Use clear headings, tables, and cross-references. Your goal: eliminate confusion before it starts.

Strong first time FDA submissions don’t happen by accident. They’re built with intention, checked with care, and written for the people who’ll actually read them.

The Cost of Getting It Wrong (and the Value of Getting It Right)

Submitting your first FDA 510(k) is a significant milestone. However, many first-time submissions encounter setbacks that can derail timelines and budgets. Understanding the potential pitfalls can help you navigate the process more effectively.

The Reality Check

According to FDA’s MDUFA statistics, approximately 65% of 510(k) submissions receive Additional Information (AI) requests, and about 60% are rejected during the initial administrative review, known as Refuse to Accept (RTA).

These statistics highlight the importance of meticulous preparation and understanding of FDA expectations.

The Ripple Effect

An AI request or RTA doesn’t just mean revising documents, it can lead to:

• Delays: Each setback can add weeks or months to your timeline, impacting product launch schedules.
• Increased Costs: Additional testing, documentation, and consulting fees can strain budgets.
• Team Morale: Repeated setbacks can affect team confidence and investor relations.

The Path Forward

While the statistics may seem daunting, they underscore the value of thorough preparation and strategic planning. Engaging with FDA early through pre-submission meetings, ensuring complete and organized documentation, and seeking expert guidance can significantly improve your chances of a successful first-time submission.

How Fission Consulting Can Help With First Time FDA Submissions

Let’s face it: navigating first time FDA submissions can feel overwhelming. You’re juggling documentation, testing, timelines, team expectations, and somewhere in the chaos, you’re supposed to “get it right” the first time.

That’s where we come in.

At Fission Consulting, we’ve walked dozens of startups and first-time submitters through the FDA process, from initial strategy to final clearance. And we don’t just check boxes. We help you understand what the FDA actually wants to see and how to present your story clearly and confidently.

Here’s what working with us looks like:

• Tailored Strategy: Whether you’re pursuing a 510(k), De Novo, or another pathway, we’ll help you pick the right path from the start.
• Submission-Ready Documentation: We help organize and polish every element, labeling, test reports, software documentation, so it’s reviewer-ready.
• Special Expertise in SaMD and Complex Submissions: We know the common pitfalls (and how to avoid them), especially with software-heavy devices.
• We Speak Reviewer: That means clear rationales, smart formatting, and an approach that reduces back-and-forth.

We’re not here to overcomplicate things or drown you in jargon. We’re here to make sure your first time FDA submission is your only submission.

Let’s make it happen, get in touch today. 

Don’t Be the Cautionary Tale

You didn’t get into this to become an FDA expert, you got into this to solve a real problem with a product that could make lives better. But even the most brilliant innovation can stall out before ever reaching patients if your first FDA submission falls flat.

Here’s the truth: most first time FDA submissions fail not because the product isn’t good—but because the process wasn’t respected.

The good news? Every misstep we’ve talked about is avoidable.

With the right strategy, clear documentation, and a team that knows how to translate your vision into regulatory language, you can avoid costly detours and get your product to market faster.

You’ve already done the hard part, building something valuable. Don’t let a preventable mistake slow you down now.