Glossary
Substantial Equivalence
Also called: SE
The 510(k) standard: a new device has the same intended use and raises no new questions of safety and effectiveness compared with its predicate.
Substantial equivalence is the legal test at the center of the 510(k) route. It compares intended use and technological characteristics. It does not compare clinical outcomes, and it does not require the new device to perform better.
Where This Gets Misread
Equivalence is judged against the predicate, not against clinical need or against current standard of care. A device can be substantially equivalent to a predicate that itself performs modestly, and nothing in the finding says otherwise.