What does the term “de novo classification” refer to?

The term “de novo classification” specifically refers to a regulatory pathway for low- to moderate-risk devices that are novel and not substantially equivalent to existing devices. This classification allows manufacturers to seek FDA marketing authorization for devices that do not fit into any existing classification category but are still considered to present a low to moderate risk to patients and users.

In this process, manufacturers can provide evidence demonstrating safety and effectiveness in situations where traditional premarket notification (510(k)) might not apply due to the absence of a comparable device. By utilizing the de novo classification pathway, new devices can be classified as either Class I or Class II, which opens the door for marketing authorization with a more streamlined process.

Understanding this classification is crucial within the regulatory landscape, especially as it fosters innovation for devices that might otherwise struggle to receive approval due to lack of a predicate device. This pathway not only enhances the availability of new medical technologies but also supports manufacturers in bringing their products to market more efficiently compared to the traditional premarket approval process, which is more suited to higher-risk devices.