Premarket Notification

Premarket Notification, also known as 510(k), is a process some medical device manufacturers use to get approval from the U.S. Food and Drug Administration (FDA). It involves submitting evidence that a new device is substantially equivalent to a device already legally on the market. This process helps ensure the device is safe and effective before it can be sold. Many medical devices, especially those that are similar to existing ones, can go through this streamlined review instead of a full FDA approval, saving time and resources while maintaining safety standards.