If you’ve ever thought, “We’ll figure it out when we file” (admit it – you’ve at least thought it) then you know what can happen when you get it wrong.
And believe me – many companies do get it wrong, some more than once. But you can sidestep that fate by taking advantage of the FDA’s pre-submission program.
The FDA pre-submission (pre-sub) is your chance to talk to FDA reviewers before you hit “SEND” on your 510(k), de novo, or PMA submission. It’s the agency’s free feedback program — and if you’re not using it, you’re flying blind.
A pre-sub lets you ask FDA a few key questions — usually three or four — about your device’s technology, claims, and testing strategy. It’s a chance to take the agency’s temperature regarding your product – to see where they nod approvingly and where they raise an eyebrow.
If your device is novel, complex, or uses new materials, a pre-sub is your best early warning system. It helps FDA understand your product before they see it in a full submission.
This is also where you start building that delicate, long-term relationship with the FDA. Because once you’ve filed a pre-sub, the FDA will never forget you. Or your device. Not ever.
The good news? It’s free.
The bad news? Done wrong, it can cost you time, money, and your FDA street cred.
What Not to Include in Your FDA Pre-Submission
Here’s a classic rookie mistake, one that I admit to making myself when I was a regulatory newbie: including too much in one pre-sub.
It’s tempting to give the FDA every minute detail about your device and it’s uber-cool technology – but this is where you need to exercise caution (and restraint). They don’t care nearly as much about your device as you do, and fire-hosing them with too much information will only hurt your submission in the end.
And if your submission involves clinical studies (Hint: most of them do), keep that conversation separate from everything else. FDA’s clinical review team is a different animal altogether, and they need focus, not distraction, so save the squeaky toy approach for another time.
And remember: FDA will review your protocols, not your data. You won’t get them to “pre-approve” your results, so don’t ask. What you can do is get their early buy-in on your study design and endpoints, saving yourself from painful rework later. It’s all about the questions you ask, and how you ask them.
How to Write Questions FDA Will Actually Answer
Here’s where most people trip up.
A good pre-sub question isn’t open-ended – it’s leading. You should already know the answer you want, and are prepared to back it up with your rationale, data, and expert logic.
You don’t want the FDA to think for themselves here, because that way lies madness. Instead, you want to gently lead them into thinking they way you do about your device, and that takes skill and no small amount of creative question-writing. My tips?
- Keep your questions short, sweet, and specific.
- Don’t make them guess what you’re asking – be clear.
- Keep it to three or four well-thought-out topics.
Don’t throw in 20 questions because you’re “just curious,” and always end your position statement with the magic words: “Does FDA concur?” That is the sure path forward to pre-sub success.
Labeling and the Elephant in the Room (a.k.a. FDA’s Memory)
Labeling used to be an afterthought. Now, it’s sits front and center in the FDA pre-submission process. Why? Because your labeling tells the story of your device: what it does, how it works, and who should (and shouldn’t) use it.
That’s why FDA wants to see your Instructions for Use (IFU) early — even if they’re just 85% baked. Look at it this way – if FDA misunderstands your product because your labeling/IFU was vague, you’ll spend your entire meeting explaining what you meant instead of discussing what matters.
You also need to make sure that your entire team — regulatory, R&D, and marketing — is on the same page. If the FDA sees one story in your submission and another on your website, well – that won’t end well for you.
And if you filed a pre-sub ten years ago, make sure you remember it, because they will. If it’s the same device (or a different version of a previous device), they’ll compare the old pre-sub to your new one, and if you ignored their feedback back then, they’ll know it. (Ask us how we know.)
Final Thoughts: Keep It Simple, Keep It Smart
The FDA pre-submission process isn’t just a formality — it’s a strategic opportunity to shape your regulatory destiny before things get expensive, political, or irreversible.
When you take the time to write a clear, well-supported pre-sub, you’re doing more than asking FDA for feedback — you’re teaching them how to think about your device. That’s powerful. It’s your chance to set expectations, influence how reviewers interpret your technology, and avoid getting blindsided later by requests for more testing or data.
But this only works if you treat the pre-sub like a real submission. That means giving FDA enough technical detail to visualize your device, showing you’ve thought through your claims, and asking specific, answerable questions that make it easy for reviewers to agree with you.
Think of your pre-sub as your device’s first impression — one that sticks with FDA for the life of your technology. So make it clear, make it concise, and make it count.
As a wise consultant once said, “Regulatory isn’t just paperwork. It’s product development, business strategy, and storytelling — all rolled into one.”
Now go forth and pre-sub like a pro.
There’s no shortage of guidance out there—but translating it into something workable is a different exercise entirely.
If you’re continuing to build out your approach, these may help:
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The full podcast discussion: How to Pre-Sub (Like a Pro)
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Video: Mastering FDA Pre-Submissions: Strategy, 513(g), Breakthrough Devices & What Actually Works
- Video: Crash Course in FDA Pre-Submissions
They cover the same ground from slightly different angles—strategy, execution, and the occasional “what not to do.”
Because in this space, knowing the rules is one thing. Applying them well is something else.
