As noted above, a 510(k) requires demonstration of substantial equivalence to another device that is lawfully marketed in the U.S. Substantial equivalence means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent to a predicate device if, in comparison to the predicate, the device:
- has the same intended use as the predicate; and
- has the same technological characteristics as the predicate;
Or
- has the same intended use as the predicate; and
- has different technological characteristics and the information submitted to FDA;
- does not raise new questions of safety and effectiveness; and
- demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
If FDA determines that a device is not substantially equivalent, the applicant may:
- resubmit another 510(k) with new data
- request a Class I or II designation through the de novo process
- file a reclassification petition
- submit a premarket approval application (PMA).
