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[content]
Apply for the FDA Pathway & Pre-Submission Meeting Program | Dovetail
FormlyAI is now Dovetail. Same team, same platform, new name. Read why.
Dovetail
Dovetail
Products
Customers
Resources
Pricing
Login
Book discovery call
Apply for the FDA Pathway & Pre-Submission Meeting Program
Three founders a month, no cost. Tell us a little about your device and where you are with the FDA. It takes about five minutes, and if you're eligible we'll be in touch to book your pathway call.
Contact information
Just so we know who you are and how to reach you if you're one of this month's three.
Full Name
*
Email
*
Company
*
Website
About your startup
Tell us about your device and where you are with the FDA. This is what we'll review before we speak, so the more you share, the more useful your pathway call will be.
What are you building?
*
In a sentence or two, what's your device and what does it do?
What's your intended FDA submission pathway?
*
This shapes your whole pathway, so a best guess is fine if you're not certain yet.
Class I
Class II
Class III
510(k)
De Novo
PMA
Not sure yet
Where are you in the pre-submission process?
*
Wherever you're starting from is fine. It just tells us where to pick things up.
Haven't started yet. Not sure what questions to ask FDA
Building our Q-Sub package now
Package ready. About to submit or just submitted
Already submitted and waiting on the FDA's response
Received an AI request or FDA feedback and need help responding
How much have you raised to date?
A rough band is plenty. It helps us understand your stage and how fast you need to move.
Pre-seed / under $500k
Seed / $500k-$2m
Series A / $2m-$10m and above
Bootstrapped or grant-funded
What's your team's level of regulatory expertise?
Tell us who's handling regulatory today, whether that's nobody yet, one person part-time, or a dedicated team.
Any other information you'd like to add?
Anything else that helps us understand your timeline, target markets, or where you're feeling stuck.
I understand spots are limited to three founders a month, and applying doesn't guarantee a place. I'm happy for Dovetail to contact me about my application and to store these details in line with the Privacy Policy.
*
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