510(k)

A 510(k) is a submission made to the U.S. Food and Drug Administration (FDA) by medical device manufacturers seeking approval to market a new device. It demonstrates that the new device is "substantially equivalent" to an already approved device, meaning it is as safe and effective. This process allows for faster approval than other pathways, ensuring that innovations in medical devices can reach patients while maintaining safety standards. Essentially, it's a way to ensure new devices are similar enough to existing ones that they can be trusted for use without undergoing the more rigorous pre-market approval process.