A 510(k) plan is only as sound as the predicate it rests on. When the predicate turns out to be one FDA won't accept, the consequences reach beyond the regulatory team: a longer timeline, new testing or clinical data, possibly a De Novo request, and a financing plan built around the wrong date.
We call it the "Predicate Trap," and it is worth checking directly in diligence.
What Is the Predicate Trap?
The 510(k) pathway requires showing that a device is substantially equivalent to a legally marketed predicate: the same intended use, and the same technological characteristics or different ones that don't raise different questions of safety and effectiveness. In practice, predicate selection takes judgment, and a poor choice can undo a regulatory strategy.
The Predicate Trap occurs when a company:
- Selects a predicate for convenience rather than true equivalence
- Relies on a predicate with a design-related recall or unmitigated safety issues
- Chooses a predicate whose intended use differs from its own
- Uses a predicate whose technology differs in ways that raise new questions of safety or effectiveness
- Builds a development program around a predicate that was never appropriate
How It Plays Out
An Illustrative Case
A surgical device company raises a Series A on a 510(k) timeline. Its predicate has a similar intended use but significantly different technology.
During review, FDA sends a request for additional information questioning the predicate, and the company has to choose between finding a better predicate and submitting a De Novo request.
Either way the timeline and budget grow, and the company may have to raise money on worse terms than it planned. This case is a composite, not a specific company.
Red Flags We Look For
How to Test for the Trap
1. Map the Predicate Landscape
Look beyond a single predicate: identify the potentially relevant ones, check their clearance histories and recall records, and understand why each would or wouldn't hold up.
2. Look for FDA Feedback
A Pre-Submission lets a company test its predicate choice with FDA before committing to it. There is no FDA user fee for it.
3. Check for a Fallback
Is there a backup predicate, and has the company thought through a De Novo request if FDA disagrees? A strategy that depends entirely on one predicate is exposed.
4. Read the Regulatory Plan Independently
For investors, a read of the predicate strategy by someone outside the company's own consultants is a useful check on assumptions no one inside has had reason to question.
The Bottom Line
Predicate strategy isn't a checkbox; it shapes the whole development program. A diligence read that examines the predicate directly, rather than accepting the company's characterization, is where the trap is easiest to spot.
References
- FDA. "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission." Draft guidance, September 2023. fda.gov
- FDA. "How to Find and Effectively Use Predicate Devices." fda.gov
- FDA. "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]." Final guidance, July 2014. fda.gov
- Covington & Burling LLP. "FDA Proposes Significant Shift to 510(k) Process in Draft Guidance on 'Best Practices' for 510(k) Predicate Selection." September 11, 2023. cov.com
- Emergo by UL. "U.S. FDA Medical Device Predicate Selection for 510(k) Submissions." White paper by Stuart R. Goldman, November 2024. emergobyul.com
- Johner Institute. "Predicate device & substantial equivalence." October 24, 2023. johner-institute.com
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