Glossary
De Novo
An FDA pathway for new kinds of low- to moderate-risk medical devices that have no existing equivalent on the market.
The De Novo pathway lets the US Food and Drug Administration authorize a novel medical device of low to moderate risk when there is no existing device it can be compared with for a 510(k). The maker must provide evidence of safety and effectiveness, and the FDA sets the controls the device type must meet.
A De Novo authorization creates a new device classification. Later products of the same type can then use the first device as a predicate and go through the 510(k) route.
Like 510(k) clearance, a De Novo authorization means the FDA allows the device to be marketed for a specific intended use. It is not a finding that the device improves outcomes in every setting.
Read more: our explainer