510(k) submission

A 510(k) submission is a regulatory process required by the U.S. Food and Drug Administration (FDA) for medical devices to demonstrate that a new or modified device is substantially equivalent to an existing, approved device. Manufacturers submit detailed information about the device’s design, materials, and performance, along with evidence showing it is safe and effective. If the FDA agrees, the device can be marketed without going through the more extensive premarket approval process. This process helps ensure medical devices are safe for use while facilitating their quicker availability to patients.