What does "predicate device" refer to?

The term "predicate device" refers specifically to a legally marketed device that serves as a reference point for a new device undergoing evaluation through the 510(k) premarket notification process. In this context, the new device must demonstrate substantial equivalence to the predicate device regarding safety and effectiveness. This comparison is crucial as it provides the FDA with a benchmark to assess whether the new device can be safely introduced to the market without requiring extensive clinical trials that may be necessary for devices classified as Class III.

A predicate device needs to be one that is already on the market, making option B the correct choice, as it accurately identifies the role of a predicate device within the regulatory framework established by the FDA for medical devices. The process hinges on ensuring that new devices are comparable to those that are already validated, therefore streamlining the approval process for manufacturers while maintaining public safety.

The other options do not accurately reflect the definition or function of a predicate device within FDA regulations concerning medical devices.