FDA 510(k) clearance

The FDA 510(k) clearance is a regulatory process that medical device manufacturers must go through to demonstrate their device is substantially equivalent to an already legally marketed device. This process allows the device to be marketed in the U.S. without additional premarket approval, provided it meets safety and effectiveness standards. Essentially, it's a way for the FDA to ensure that new medical devices are similar in safety and performance to existing, approved devices, helping protect patient health while facilitating access to innovative medical technology.