Formly
Formly Regulatory Pathways

FDA pathway & pre-submission meeting program

Your Q-Sub meeting is one of the most valuable conversations you'll have on the road to the FDA clearance. Most founders go in at the wrong stage, with the wrong questions, or skip it entirely. We'll get you prepared wherever you are in the process, and we're opening the program to three founders a month, at no cost.

Apply for the program
About the program

Meet the FDA where you are.

The FDA pre-submission process isn't a single on-ramp. Some founders come to us with a submission already filed. Some have materials ready and want to sharpen what they're asking FDA before it goes in. Some are starting from zero and aren't yet sure what questions to bring. All three can make good use of a Q-Sub meeting, and all three need different preparation to get there.

This program doesn't run a fixed sequence, we start from where you actually are, do the thinking that turns your current position into a productive FDA conversation, and support you through it. You're at one of these three places, we'll meet you there.

Apply for the program

  1. Already submitted

    You've filed and you're waiting, or the FDA has come back with questions and you're not sure how to respond. We review your submission and any FDA correspondence, identify what matters most, and give you a clear strategy for the next conversation. You'll go in knowing exactly where you stand and what to say.

  2. Materials ready

    You have a Q-Sub package drafted but want it stress-tested before it goes to the FDA. We review what you've built, sharpen the questions you're putting to the agency, and flag anything likely to slow the process or invite a harder conversation than you need at this stage.

  3. Starting from scratch

    You know you need a pre-submission meeting but don't yet know what to ask. We build your Q-Sub question framework, mapping the right questions to your specific device, intended use, and regulatory pathway, so you walk into the meeting with a clear agenda and the FDA knows you're prepared.

The most valuable FDA conversation you'll have isn't the formal one.

The pre-sub meeting is your best shot at informal FDA input. Most founders don't use it well.

You don't know what to ask.

The value of a pre-sub meeting depends entirely on the quality of your questions. Vague questions get vague answers. Go in without a tight framework and FDA can only respond to what you give them, which means you come out with less than the meeting was worth.

Your timing is off.

Submit too early and you're asking the FDA to evaluate work that isn't ready. Wait too long and you've already committed to a pathway that might be wrong. The window where a Q-Sub meeting genuinely moves the needle is narrower than most founders realise, and it closes faster than they expect.

You're going in alone.

The FDA doesn't tell you how to prepare. Founders who haven't been through a Q-Sub before often don't know what level of detail the agency expects, which questions are worth asking, or what format gets taken seriously. Walking in underprepared costs you the one low-friction feedback opportunity you have before the formal submission clock starts.
That's why we created the FDA pathway & pre-submission meeting program

Apply for the program

Complete a short application and tell us where you are in the Q-Sub process. Eligible founders will be invited to join the program. We take three founders a month and review applications in the order they arrive. Once the month's spots are full, applicants join the waiting list. It costs nothing but the time it takes to apply.

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Trusted by some of the most complex device companies across markets.

Thank God we found Formly. They saved us 3–5 years by giving us the right advice and sparing us from having to navigate it all ourselves. They are true partners, not vendors. We truly feel they are here with us.

Christiaan FultonChromacare
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