510(k) submissions

A 510(k) submission is a process used by medical device manufacturers to demonstrate that their device is as safe and effective as a legally marketed device already on the market, called a predicate device. The FDA reviews this application to ensure the new device's safety, performance, and equivalence. If approved, the device can be marketed in the U.S. without going through the more extensive premarket approval process. This process helps bring new medical devices to patients more efficiently while maintaining safety standards.