A founder forwarded me the FDA notice this week with a one-line note: “Less paperwork, finally.” I read the same notice and went the other way. On June 5 the FDA published guidance saying it intends to exempt a set of unclassified medical devices from premarket notification, the 510(k) step, and that it will not enforce the requirement while the exemption is finalized. Most founders read a sentence like that as time and money handed back to them. Sometimes it is. But a 510(k) requirement is not only a cost you pay. For the company already on the market, it is a wall standing between them and the next entrant, and the FDA just started taking some of those walls down.
What the FDA Actually Did
The June 5 guidance is narrow on its face. It covers unclassified devices, the older products that predate the agency’s modern classification system and were never formally sorted into Class I, II, or III. The FDA now believes a short list of them are low enough risk to skip premarket review, so it is moving them toward exemption and holding off on enforcement in the meantime, which means it does not expect a 510(k) for those products today. On its own, a housekeeping notice.
It is not on its own. Back in February the FDA published a separate request for comments naming a list of Class II devices it intends to exempt from premarket notification once finalized, per the Federal Register. Two notices in four months, one for legacy unclassified products and one for moderate-risk Class II devices, point the same way: the agency is pulling categories of hardware out of the 510(k) process rather than into it. For a founder mapping a pathway, the fact that matters is not which specific products moved this week. It is that the line of what needs a 510(k) at all is shifting, and it is shifting while you build.
A Filing Requirement Is Also a Wall
Here is the part the relief reaction misses. The 510(k) is a gate, and a gate works in both directions. When I was at Galen, our pathway turned into a de novo, and the lesson I took from it is one I now repeat to every device founder: clearing a hard regulatory bar costs you, but it also hands you something. A barrier you get to stand behind once you are through it. The de novo let us write the regulation and become the predicate every later entrant had to match. A 510(k) does a quieter version of the same thing. As long as a category requires premarket notification, a new competitor has to assemble a submission, find a predicate, and convince a reviewer before they can sell against you. That friction does free work for the incumbent every single day.
Exempt the category and the friction is gone. The next entrant can build and ship without ever filing. If part of your product’s edge was that the regulatory path was hard, the exemption just lowered the wall for everyone behind you. The savings came off your filing budget and out of your barrier to entry at the same time.
Who Should Cheer, and Who Should Re-Plan
This is not a reason to mourn every exemption. If you are pre-market and the device you are building just landed on an exempt list, you got a real gift: faster, cheaper entry into a category you were about to spend a year and six figures clearing into. Take it. The founders who should re-plan are the ones whose defensibility was leaning on the filing itself. Single-product device companies in a newly exempt class. Anyone whose deck cites “regulatory barrier to entry” as a moat. If a reviewer no longer stands between your category and a fast follower, that line is now decoration, and your defensibility has to come from somewhere the FDA does not hand out: a validated claim a competitor cannot copy from the outside, a clinical dataset, a manufacturing process, switching costs that are real. The exemption will not build any of that for you. It just takes away the excuse to keep putting the question off.
Dave’s take
Deregulation gets sold to founders as pure tailwind, and that framing is lazy. Every requirement the FDA drops is a cost off your books and a door held open for the next person who wants your customers, and which of those two matters more comes down to whether you are the incumbent or the insurgent in that category. I would rather a founder know which one they are this quarter than find out the morning a competitor ships without filing anything at all.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →