FDA, the Friendly Monster
May 06, 2026
FDA Pre-Submissions are one of the most underused tools in early-stage device development.
Many founders don't know this conversation is even available to them.
A Pre-Sub is a formal mechanism through which companies can request a meeting, written feedback or a teleconference directly with FDA prior to submitting a formal application. It’s a chance to have productive dialogue with the agency before you've committed to a regulatory pathway, before you’ve locked your design, and, hopefully, before you've spent years heading in the wrong direction.
Used well, it's essentially a pre-game conversation with the referee.
Most founders think of the FDA as something to be feared and avoided — a regulatory monster lurking at the end of the development road. But the monster, it turns out, can actually be one of the most useful partners you have in early development. Companies who treat the FDA as a resource to engage early and often are often the ones who move the fastest.
Here are a few things a Pre-Sub can help you clarify:
- Whether your device fits a 510(k), De Novo, or PMA pathway
- Whether your predicate selection will hold up
- What FDA expects in your clinical or bench testing plan
- How a novel technology might be evaluated
The program is free. FDA typically responds within 90 days. And the clarity you gain is worth far more than the time it takes to prepare the briefing document.
If you're in early development and you haven't had this conversation yet, maybe it’s time to face the monster.
Support for MedTech at Every Stage
Archimedic partners with medical device teams to solve complex design, development, regulatory, and go-to-market challenges.
