A predicate device (PD) is a medical device that may be legally marketed in the U.S, and used as a point of comparison for new medical devices seeking approval through FDA’s 510(k) premarket clearance pathway. The predicate allows manufacturers to demonstrate that their new device is substantially equivalent to a device already approved to be legally marketed in the U.S. There are two categories of predicate device.
The FDA recommends that manufacturers choose a predicate that is most similar to their device with regard to indications for use and technological characteristics. Other criteria include to help build the case for proving a device is substantially equivalent to a predicate include: design, energy used or delivered, materials, performance, safety, effectiveness, labelling, and other appropriate considerations. In addition to these criteria, choosing a more recently approved predicate device is preferred due to the rapid changes in technology since 1976. The FDA is considering updating its rules to require that predicate devices be less than ten years old.