Crossing the Atlantic? Four Things Every UK Medtech Founder Must Pack Before Facing the FDA.
America turns 250 this year. For UK medtech, the US market is still the market worth crossing an ocean for. Standing at the door to the US market is the FDA, and (surprise!) it works nothing like the MHRA or a Notified Body.
For many of us, we see that as an opportunity. The FDA is more navigable than its reputation suggests, and the founders who struggle with it are almost always the ones who “packed” for the wrong country. So before you sail, here is what belongs in your metaphorical trunk.
1. Your intended use and product code, packed first
Everything downstream flows from two things. What you claim your device does (your intended use), and the FDA product code that claim drops you into. Get these right and your pathway, your testing, and your requirements fall into place. Get them wrong and you'll redo months of work.
And if your product code points to an FDA guidance document, read it. The FDA calls guidance "non-binding recommendations." In practice though, you should treat it as gospel, because that is what your FDA reviewer does.
2. A predicate, or a clear-eyed decision to go without one
The most popular path to market in the US, the510(k) route, runs on the predicate system. If you can show that your device is substantially equivalent to something already cleared and on the market, then you ride the 510(k) pathway, where the FDA targets 90 days of review time for your eventual submission. No good predicate exists? That's not a dead end. You likely qualify for the De Novo pathway, for novel low-to-moderate-risk devices, where the review time is a longer target of around 150 days by FDA.
3. A US Agent, non-negotiable and easy to forget
As a foreign manufacturer, you legally cannot register with the FDA without a designated US Agent. That means a real person or company, physically in the US, reachable by phone during business hours. No PO boxes, no answering services. They field FDA communications and help schedule inspections. Skip it and your registration simply won't complete, so your device can't legally enter the country. Sort it early. It's an administrative tripwire that but easily fixable early.
4. A Pre-Submission, the FDA's free front door
Before you spend nine months building a submission, you can ask the FDA what they think of your plan. In writing, for free, with a response in about 75 days. It's called a Pre-Sub, and it's the single highest-leverage move on the whole journey. Done well, it saves 6 to 18 months of building the wrong thing.
A few hard-won rules for packing this one.
- File at the right moment. As you’re nearing design freeze, before you've sunk any money into verification testing. Too early and you won’t have enough of your design or intended use solidified for the FDA to give proper feedback. Too late and a redesign hurts.
- Don't ask the FDA to write your strategy. Ask if they agree with yours. "Should we run a clinical trial?" is like asking a child if they'd like some candy. The answer is always yes, and always the most conservative path. Bring a plan with a rationale, then ask them to confirm or correct it.
- Send enough to answer the question. Asking about biocompatibility? Include your materials breakdown. Half-answered Pre-Subs are almost always self-inflicted.
- Treat the meeting as the real prize. Always request the live meeting, not just the letter with feedback. The verbal feedback goes deeper than anything written down and allows you to answer more questions and clarify what FDA really means in their responses.
One more thing. A Pre-Sub is FOIA-able, so keep trade secrets out of it. And it's the FDA's first impression of you, so take their advice in your eventual submission, or be ready to explain why.
Heading west? We'll help you pack.
A guidance document or a chatbot will give you an answer on classification or scope, and it can be confidently wrong, because it doesn't know which arguments regulators have actually accepted and which they've thrown out. That knowledge isn't public. You learn it by doing it. Get scope wrong at the start and it compounds into wrong requirements, broken validation, and a submission that unravels.
Dovetail is built for that gap. We're not a consulting firm and we're not an eQMS. We’re a team of regulatory experts, a validated platform, and an AI layer trained on devices we've actually cleared. One system, not three. Expert-led, AI-enabled, audit-ready. We've been in the room with the FDA and notified bodies, and we build the documentation you hold in-house, so we know it will pass.
We get in the mud with your team from day one and shape scope for what wins in two years, not just six months. And unlike an hourly consultant you put off calling, with fixed pricing you can reach out the moment something comes up and save yourself from any expensive mistakes right away.
The US on your roadmap? Our FDA Pathway & Pre-Submission Meeting Program takes you from wherever you are standing to a Q-Sub meeting you can actually use. We frame the strategy, draft the questions, build the package, and sit in on the meeting. Three spots a month, at no cost
Not ready for the program, or just want to think out loud about your US plans? That's fine too. Book a free 30-min call with the Dovetail team.
Dr Spencer Todd is the CEO and co-founder of Dovetail (formerly FormlyAI), a regulatory partner for medical device companies. Before founding Dovetail, he spent years at the FDA and as a medical device consultant.
