510(k), De Novo, or PMA: Which FDA Pathway Is Yours?
A plain-language guide to the three main FDA device pathways and how to tell which one applies to your product before you write a grant.
Most first-time medtech founders treat the FDA pathway as a problem for later. It isn’t. The pathway determines your timeline, your budget, and how much evidence a grant reviewer expects you to have already thought through. Picking the wrong one in your Specific Aims is a credibility tax you don’t need to pay.
Here’s the short version of how the three main pathways differ.
The 510(k) pathway
A 510(k) clears a device by showing it is substantially equivalent to a device already on the market — a predicate. If you can point to a legally marketed device that does roughly what yours does, in roughly the same way, with the same intended use, you’re likely in 510(k) territory. This is the most common pathway and the fastest to plan around.
The work is in the comparison: same intended use, same technological characteristics, and any differences don’t raise new questions of safety or effectiveness.
The De Novo pathway
De Novo exists for devices that are genuinely novel but low-to-moderate risk — there’s no predicate, but the device isn’t risky enough to justify the full PMA burden. If your classification search comes up empty and your device isn’t life-sustaining, De Novo is often the answer.
A “no predicate found” result isn’t a dead end. It’s frequently the signal that you’re looking at a De Novo, not a PMA.
The PMA pathway
Premarket Approval is the most rigorous route, reserved for high-risk (Class III) devices that sustain life or present significant risk. It requires clinical evidence and is the longest and most expensive path. Most early-stage products are not PMA — but if yours is, you want to know on day one.
How to figure out yours
Start with the device classification database and search by what your device does, not what you call it. Find the product code, read the regulation, and check the 510(k) database for cleared predicates. If predicates exist, you’re likely 510(k). If none exist and risk is moderate, look at De Novo. If your device is life-sustaining, assume PMA until proven otherwise.
This is exactly the analysis RegReady automates — but even doing it by hand once will sharpen every regulatory sentence in your next grant.