What is Substantial Equivalence

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What is Substantial Equivalence

Substantial Equivalence requires demonstration of reasonable safety and effectiveness of device.

SE (Substantial Equivalent) means that the new device is as safe and effective as the predicate device(s).

A device is SE (Substantial Equivalent) if, in comparison to predicate device it:

• has the  same intended use as the predicate device; 

and

• has the same technological characteristics as the predicate device;

or

• has different technological characteristics as the predicate device that do not raise new questions of safety and effectiveness and is demonstrated as safe and effective as legally marketed device.

Once device is determined SE, it can then be marketed in U.S.

FDA Approved device search will show the following on device search results: 

Decision:  Substantially Equivalent (SESE)