Which regulation requires premarket notification for devices in the U.S.?

The regulation that requires premarket notification for devices in the U.S. is the 510(k) submission. This process is essential for manufacturers to demonstrate that their medical device is substantially equivalent to a device that is already on the market. By submitting a 510(k), a manufacturer must provide evidence that their device is as safe and effective as the predicate device, thereby allowing it to be marketed without the need for extensive preclinical and clinical trials, which are required for more novel devices.

The significance of the 510(k) submission lies in its role in ensuring patient safety while facilitating quicker access to new medical technologies. This regulatory pathway is utilized when a new device has similar intended use and technological characteristics as an existing device, highlighting the FDA's approach to balancing innovation with regulatory oversight.