A device that is compared to in a premarketing submission is referred to as what?

The term that is used to describe a device compared to in a premarketing submission is "predicate device." In the context of regulatory submissions, particularly in the United States, a predicate device is an existing device that has already been legally marketed and is used as a benchmark to demonstrate that the new device is safe and effective.

The predicate device must have similar indications for use and technological characteristics to the new device. Utilizing a predicate device allows manufacturers to pursue a 510(k) premarket notification, demonstrating that the new device is "substantially equivalent" to the predicate. This requirement is essential for the FDA's review process, as it helps to ensure that new medical devices meet the necessary standards for safety and efficacy based on established devices.

Therefore, the correct identification of a device in terms of what a new device is compared against in its premarket submission is fundamental in the regulatory pathway for medical devices.