FDA explains substantial equivalence as a way to show the new device is safe and effective as the predicate. Substantial equivalence is essential as a 510(k) necessitates display of substantial equivalence to another legally U.S. marketed device.
A device can be substantially equivalent only if it proves to have –
The same intended use as the predicate device; and
The same technological characteristics as the predicate device; or,
Different technological characteristics, that do not raise new questions of safety and effectiveness, and the device is as safe and effective as the predicate.
