Premarket Notification (510(k))

A Premarket Notification, known as 510(k), is a submission that medical device manufacturers send to the U.S. Food and Drug Administration (FDA) to demonstrate that a new device is substantially equivalent to an existing, legally marketed device. This process helps ensure the device is safe and effective before it can be sold in the U.S. The 510(k) review assesses technical and safety aspects, allowing the FDA to approve the device's market entry if it meets regulatory standards. It streamlines the approval process for devices that are similar to already approved products.