What does the term "substantially equivalent" refer to in a regulatory context?

The term "substantially equivalent" in a regulatory context specifically refers to a device that has similar characteristics to a previously cleared device, known as a predicate device. This concept comes into play particularly in the 510(k) premarket notification process used by the FDA.

When evaluating whether a new device is substantially equivalent, the focus is on comparing its intended use, technological characteristics, and performance to those of a predicate device. If the new device is found to be similar in these aspects, it can be cleared for marketing without the need to undergo the more rigorous premarket approval process that applies to higher-risk devices.

This concept is essential because it allows for innovation and new products to enter the market while ensuring a level of safety and efficacy based on existing devices. The idea is that if the new device is substantially equivalent to one already on the market, it should pose similar levels of safety and effectiveness for patients and users.