Which FDA pathway applies: 510(k), De Novo, or PMA?

In short: 510(k) if a substantially equivalent predicate device exists; De Novo if your device is novel but low-to-moderate risk with no predicate; PMA if it is high-risk Class III. Most health software targets a 510(k) where a predicate exists — which makes predicate research the first real task.

The decision in practice, not just in theory

The three pathways aren't equally likely for most software products. 510(k) is the route for devices with a reasonably close predicate already legally marketed with the same intended use and comparable technological characteristics — this covers the majority of health software, since the category has matured enough that genuinely first-of-kind products are less common than founders sometimes assume. De Novo applies when your device is novel enough that no predicate exists, but its risk profile is still low-to-moderate and general controls (or general plus special controls) are sufficient to provide reasonable assurance of safety and effectiveness — a granted De Novo request also creates a new device classification that others can later use as a predicate. PMA is reserved for the highest-risk, Class III devices, requiring the most extensive clinical evidence and the longest, most expensive review.

Why predicate research comes first, not classification

Because most software targets 510(k), the practical first task isn't abstractly deciding which pathway sounds right — it's searching for a genuinely comparable predicate. That search itself decides the pathway question: a device with no defensible predicate isn't really facing a 510(k)-vs-De Novo choice so much as discovering which one it actually qualifies for. If predicate research turns up nothing close, that's the signal to shift toward De Novo rather than forcing a weak 510(k) argument.

Terminology worth getting right early

FDA "clears" 510(k) submissions, "grants" (authorizes) De Novo requests, and "approves" PMA submissions. These words aren't interchangeable, and using "approved" loosely in marketing for a cleared or De Novo-granted device is both inaccurate and a compliance risk in its own right.

Where next: 510(k) vs De Novo vs PMA: Which FDA Pathway · What is a predicate device, and how do I choose one?

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