Most early-stage device companies submit their first 510(k) without a dedicated regulatory affairs lead on staff. Some use a consultant, some rely on the founder's clinical background, and a surprising number try to piece it together from public FDA guidance documents and online forums. The results vary. A lot.
Marcus Elliot, our partner who spent 18 years in medical device clearance before joining Basil Health, sat down with our team recently and walked through what he consistently sees go wrong — and right — in early submissions. This is a condensed version of that conversation, written up for the founders we work with who are approaching this for the first time.
The predicate is everything
The 510(k) pathway exists because FDA can grant clearance for devices that are "substantially equivalent" to something already on the market. That's the predicate device. Founders often treat predicate selection as a formality — find anything that looks similar and move on. This is a mistake that can cost you months.
A good predicate has three qualities: similar intended use, similar technological characteristics, and a cleared classification that's appropriate for your device. The order matters. Intended use comes first. You can have a device that looks almost identical to an existing cleared product but operates under a different intended use, which can push you toward De Novo or even PMA. Starting the predicate search from the technology side and working backward to intended use is backwards, and FDA reviewers notice when submissions are structured this way.
The FDA's 510(k) database is public, and most founders search it by product type. A better approach is to search by the problem you're solving — the clinical indication — and then filter for cleared devices. The predicate that serves you best legally may not be the one most similar to your product technically.
Q-submissions exist for a reason
Before you write your 510(k), request a Pre-Sub meeting (formerly Q-Sub). This is a formal meeting request with the FDA's Center for Devices and Radiological Health (CDRH) where you can ask specific questions about your regulatory strategy before committing to it. FDA responds in writing, and those responses give you a level of certainty that no consultant can replicate.
The Pre-Sub process takes roughly 90 days from request to meeting. Many founders skip it because it feels slow and because their advisors tell them they already know the answers. That's usually overconfidence. We've seen submissions where a straightforward Pre-Sub question — "Is our intended use appropriate for the 510(k) pathway?" — would have saved 8 months of back-and-forth. The FDA reviewers are generally reasonable people who want to clear good devices. Let them tell you what they need.
Performance testing: the underestimated piece
The technical section of a 510(k) requires bench testing, biocompatibility data, software validation (for software-enabled devices), and often clinical performance data. New founders frequently underfund this piece. They budget for their predicate analysis, they budget for the regulatory consultant's time writing sections, and then they get to the performance testing requirements and realize the testing protocols alone require six weeks and the equipment access they don't have.
Build the testing timeline before you build the submission timeline. A reasonable rule: if your device has direct patient contact, budget 16-20 weeks for biocompatibility alone (ISO 10993 testing isn't fast). If you have software, budget 8-12 weeks for formal IEC 62304 documentation. These aren't negotiable. Submitting without them results in a "hold" that resets your clock.
The deficiency letter is not failure
FDA sends Additional Information (AI) requests — deficiency letters — when a submission is substantively reviewed but has gaps. Most first-time submissions receive at least one. This is normal. The clock pauses during AI response periods, which is worth knowing when you're managing investor timelines.
What matters is how you respond. FDA reviewers identify specific deficiencies, not hints. Read them literally. If they're asking for data on X, give them data on X — not a reframing of why X is less relevant than Y. Some founders try to negotiate their way out of AI requests by making arguments. This almost never works and often creates follow-up questions. Answer what's asked, document it thoroughly, and get it back in 90 days or less.
When to hire versus when to contract
This depends heavily on your device class and development stage. For a Class II device going through 510(k), a strong external regulatory consultant is often more efficient than an in-house hire at the seed stage. Consultants with CDRH-specific experience know the reviewer team, understand the current standards, and have submitted dozens of similar packages. That institutional knowledge is hard to replicate in a first hire.
The calculation changes once you have a cleared device and are managing post-market surveillance, planning international submissions, or building toward PMA for a Class III device. Those situations benefit from someone embedded in the company who understands the full context of the product and its clinical use. That's when an internal VP or Director of Regulatory Affairs earns their weight.
Regulatory strategy isn't a compliance exercise. It's a competitive decision. The founders who understand their clearance pathway as intimately as their product architecture are the ones who move fastest when it matters.
We invest in device companies regularly, and regulatory clarity is one of the first things we evaluate. Not because we want to check a box, but because it tells us something real about how the founding team thinks about risk and planning. A well-structured regulatory strategy is early evidence of operational maturity. It's one of the reasons Marcus joined our team — his presence in diligence conversations changes the quality of information we get.
If you're approaching your first 510(k) submission and want to pressure-test your strategy, reach out. We're direct about what we see and what concerns us, and these conversations are often more useful than anything you'll find in FDA's own guidance library.
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