Compliance
Predicate device
TL;DR
A legally-marketed device used as the comparator in a 510(k) substantial-equivalence determination.
A predicate is a device already on the US market (cleared under 510(k), grandfathered pre-1976, reclassified down from PMA, or granted via De Novo) to which the sponsor compares its new device. Substantial equivalence means same intended use AND either same technological characteristics or different characteristics that do not raise different safety/effectiveness questions and that are supported by performance data.
FDA's 2023 'predicates and performance criteria' draft guidance discourages cascading equivalence to very old predicates with weak performance evidence.
Regulatory anchors
- 21 CFR 807.92
- FDA Guidance: The 510(k) Program
Related terms
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