For a 510(k) device, choosing a predicate is one of the earliest regulatory decisions a company makes, and one that FDA reviewers and investors both look at closely. A weak or mismatched predicate can slow clearance, and it tells a diligence team the regulatory strategy may not have been thought through. Predicate quality can be checked against public FDA data, so a company can test its choice before investors do.
1 Substantial equivalence is a claim you have to defend
The new device must have the same intended use as the predicate, and either the same technological characteristics or different ones that don't raise different questions of safety and effectiveness. Diligence teams pull the predicate's 510(k) summary from FDA's 510(k) database and check whether the equivalence story holds.
How to close it
Write the equivalence argument before you file. If your device differs materially, name the difference and the data that addresses it.
2 A predicate's safety record comes with it
FDA's September 2023 draft guidance on predicate selection recommends predicates without unmitigated use-related or design-related safety issues and without an associated design-related recall. A predicate's recall history is public in FDA's Medical Device Recalls database, and adverse event reports are in FDA's MAUDE database, which has known limits and needs careful reading.
The trap
Picking the most convenient predicate without checking its recall and adverse event record. Investors can check it too.
3 Multiple predicates are allowed; split predicates are not
FDA's substantial equivalence guidance encourages a single predicate. A submission can use more than one, for example to combine features from predicates that share the same intended use, as long as it names a primary predicate. What FDA calls a "split predicate" (one device for intended use and a second device, with a different intended use, for technological characteristics) is inconsistent with the 510(k) standard. A reference device can support test methods or data, but it isn't a predicate.
How to close it
Map the predicate argument explicitly: the primary predicate, any additional predicates and why they share its intended use, and any reference devices and what they support.
The bottom line
Predicate selection is an engineering and regulatory judgment, not a search for the easiest match. A predicate that holds up on intended use, technology and safety record is worth more than a convenient one, and it makes both FDA review and investor diligence easier.
References
- FDA. "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]." Final guidance, July 28, 2014. fda.gov
- FDA. "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission." Draft guidance, September 2023. fda.gov
- FDA. "510(k) Premarket Notification" database. accessdata.fda.gov
- FDA. "Medical Device Recalls" database. accessdata.fda.gov
- FDA. "Manufacturer and User Facility Device Experience (MAUDE) Database." accessdata.fda.gov
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