510(k), De Novo, and the US route for software startups, an honest primer

Most of what we write assumes an EU-first route to market, because that is where our users start. But most founders eventually ask about the United States, usually the moment a US customer or investor appears. Here is the honest primer: what the pathways are, how the logic differs from the EU, and how to sequence US plans if you are building your QMS today.

The mental model shift

The EU asks "which risk class are you?" and scales scrutiny accordingly, with self-declaration available at the bottom. The FDA asks a different first question: "what are you substantially equivalent to?" US market access for most software devices runs through comparison with something already legally on the market, a predicate device.

510(k) is that comparison pathway. You demonstrate your device is substantially equivalent to a predicate, the FDA reviews, and clearance follows, commonly a six-to-twelve-month affair including preparation. Most software devices that reach the US market go this way.

De Novo exists for the genuinely new: moderate or low risk devices with no predicate. You make the case for a new classification, and if granted, your device becomes the predicate others cite later, which is a strategic position, not just a regulatory outcome. Expect more evidence, more dialogue, and more calendar than a 510(k).

Exempt is the quiet third path: some low-risk software categories require no premarket submission at all, just registration, listing, and compliance with quality regulation. Whether you fit an exemption depends on your intended use, the same sentence that drives the EU questions too.

The part that transfers: your QMS

Here is the good news for anyone building an ISO 13485 QMS right now. The FDA's quality regulation, the QMSR, which replaced the old Quality System Regulation in February 2026, incorporates ISO 13485 by reference. The decades-old problem of maintaining one quality system for Europe and a differently-shaped one for the US has largely dissolved. A well-built 13485 QMS is now the backbone of both, with a thin layer of FDA-specific requirements on top, records, labelling specifics, and FDA-facing procedures.

The same is true of your engineering evidence. IEC 62304 lifecycle records and ISO 14971 risk files are recognised by the FDA through its consensus standards programme. Requirements, system tests, SOUP register, traceability: it serves both submissions. Nothing about preparing for the EU is wasted money on the road to the US.

How EU-first startups should sequence it

Our standing advice, knowing individual cases vary: decide your first market deliberately, build the shared foundation once, and do not run two submissions in parallel on a seed budget. The shared foundation, classification logic, intended use discipline, QMS, 62304 evidence, risk file, is 70 to 80 percent of the work for either market. The submission layer differs, and each deserves focused attention with specialist support: a US regulatory consultant for the 510(k) or De Novo strategy is one of the places we genuinely recommend spending money, particularly for predicate selection, where experience beats research.

The wrong version of this plan is the one where US ambitions freeze EU progress, or where a founder pays for a full FDA strategy two years before a US customer exists. Markets are sequenced with revenue, not with anxiety.

Where QualiHQ stands on the US today

Straight answer: QualiHQ's guided path today is EU-shaped, ISO 13485, IEC 62304, ISO 14971, EU MDR, and a dedicated US track is on our roadmap rather than in the product. Because of the QMSR convergence above, the QMS and engineering evidence you build in QualiHQ now is the same foundation a US submission needs, and founders heading stateside use it exactly that way, with a specialist handling the submission layer.

If a US track would change your plans, tell us, the order of our roadmap is genuinely shaped by who asks.

And whichever flag is on your first market: the sequence starts in the same place. Know what you are building in regulatory terms, our classifier answers the EU version in five minutes, and the intended-use discipline it forces transfers directly to the FDA conversation. One foundation, then one market at a time. It is a longer road than a pure SaaS launch, but it is a road, not a wall.