A “510(k) submission” is made to FDA by a manufacturer or distributor of a medical device that is not subject to premarket approval. The “510(k)” includes information demonstrating that the medical device to be marketed is substantially equivalent to another medical device that is currently sold legally in the U.S. Substantial equivalence means that the 510(k) sponsor must demonstrate that their device has the same intended use as the legally marketed device and has the same technological characteristics. If the technology differs, they must demonstrate that it raises no new questions of safety and effectiveness.
