Welcome to my Digital Health Regulatory Pathways Master Class series. This series breaks down the core concepts every founder should understand about US and EU regulatory pathways, from what qualifies as a medical device to how risk classification affects your timeline, cost, and market strategy.
You’ve landed on #6 of this series, where I give some simple pointers how who to make your ultimate decision regarding where to launch, easier.
The truth is, whether you launch in the U.S. or an EU country will depend on a lot of factors that go beyond the regulatory pathway itself. The biggest determinant, of course, is where you can best market your product.
That said, it’s still important to think about regulatory strategy and pathways at the outset. Here are my tips. You can delve into the specific pathways I’ve laid out at the end of this blog post (tl;dr).
Assuming you have a moderate-risk device (i.e., Class II), the FDA’s 510(k) pathway is hands down the fastest and easiest. We’re talking some prework in the lead up to submission and then no more than 6 months and $6,000 to marketing your product in the U.S. You really can’t beat that timeframe and cost.
Yes, there is a little bit of prework so the process isn’t totally effortless. You will have to determine if your product has a predicate (or a handful of predicates if your product has multiple functions) that can be used to show substantial equivalence. This requires research and analysis of already-approved devices, and then setting up a meeting with the FDA (not mandatory but highly recommended) to see if they buy your argument for substantial equivalence. But given that this approach costs a total of about $6,000, it would be foolish not to at least consider it.
Even if you’re unsure if you want to market your product in the U.S., having this stamp of approval from the FDA can also greatly support your future funding efforts. I highly encourage all founders with products that could be viable in the U.S. market (which is essentially almost every product, given how huge and varied the U.S. market is, see my post on the U.S. Healthcare System) to at least explore the 510(k) option. I also encourage founders to start this process early – super early – so that they can develop a product that is already aligned with the technical specifications (like materials used, algorithms, etc) of existing products so that this pathway stays open to you.
Descriptions of the main FDA pathways:
The FDA 510(k) is a premarket notification process used to gain clearance from the U.S. Food and Drug Administration (FDA) to market a new medical device by demonstrating its substantial equivalence to a legally marketed predicate device. In other words, it’s the FDA’s way of saying, “we don’t want to hold up incremental innovation in medical devices. If you can show us that your device is similar to one that’s already been approved in terms of intended use and technical specifications, we’ll waive our detailed review of your product. Just give us 90 days, $6,000, and you’re good to market it in the U.S.
If you can’t find a predicate for your low-ish risk device (again, anything under Risk Class III), and the U.S. offers you a viable market for your product, I would suggest you attempt the De Novo process. At ~$30,000, it’s still cheaper than getting approved through a Notified Body in the EU. In theory, the timeline is also shorter, with the goal to review all De Novo submissions within 150 days (but they can stop the clock if they have questions, which some have suggested the FDA is doing a lot these days). However, you should expect a lot of presubmission meetings, in which you and the FDA determine the types of evidence needed as proof of your device’s safety. Finalizing all this can take time.
This pathway is essentially how the FDA approves a new drug or biologic. You have to do extensive clinical trials to show safety and efficacy. For small businesses, it costs around $150,000 and will take you about 2 years to complete.
This pathway is for low-risk medical device products that the FDA doesn’t even bother reviewing as part of the usual notification process. It’s equivalent to the ‘self-certification’ pathway in the MDR. Unfortunately, it is rarely applied to SaMD.
If you can’t find a predicate for your low-ish risk device (again, anything under Risk Class III), and the U.S. offers you a viable market for your product, I would suggest you attempt the De Novo process. At ~$30,000, it’s still cheaper than getting approved through a Notified Body in the EU. In theory, the timeline is also shorter, with the goal to review all De Novo submissions within 150 days (but they can stop the clock if they have questions, which some have suggested the FDA is doing a lot these days). However, you should expect a lot of presubmission meetings, in which you and the FDA determine the types of evidence needed as proof of your device’s safety. Finalizing all this can take time.
If you happen to be one of the rare founders with a bona fide Class I medical device (true unicorns, as I’ve described here), self-certifying your product in the EU is clearly the best path forward. What this means is that you prepare all the required documentation (which is not a light lift but is unavoidable) and then register your product in EUDAMED to retrieve your CE mark. THAT’S IT! Now, as I’ve mentioned, it’s rare to actually have a risk class I medical device since the MDR went into effect, but if you do, by all means, self certify in the EU!
Unfortunately, unless your device falls into a 510(k) Exempt category (think blood pressure cuffs; sadly, not SaMD), I do not recommend the U.S. pathway for Class I devices. First of all, the FDA has decided not to regulate most low-risk SaMD (again, see my post here). This means you no longer need FDA approval to market your device. That’s great if you simply want to launch in the U.S. market as a wellness app, but if you’re looking to market a real medical device with an FDA stamp of approval, you would have to take it through the De Novo process, which is more involved and costly than simply self-certifying under the EU system.
In the case of a high-risk device, the burden and costs for the FDA pathway (Pre-market approval) and the EU/MDR pathway (Notified Body review + Clinical trials) are somewhat more equivalent. If you’re manufacturing a high-risk product, my advice is to do your market research first, and then carefully plan your clinical trials for that market.
Founders who treat regulatory as a last-minute hurdle often pay for it—through delays, rework, and missed opportunities.
But if you treat it as a strategic tool, you gain leverage:
I created a table below attempting to summarize everything for you. 🙂
Really. If you have a question, submit it through this form. I will try my best to respond within a business day. Good questions will get featured on my FAQs list.
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