De Novo Classification (FDA)
An FDA regulatory pathway for novel, low-to-moderate risk medical devices that have no legally marketed predicate device. De Novo creates a new regulatory classification and can serve as a predicate for future 510(k) submissions.
The De Novo classification pathway provides a route to market for novel medical devices that are low-to-moderate risk but have no predicate device for a traditional 510(k) submission. Before De Novo was formalized, such devices would default to Class III (requiring PMA), even when the risk level did not warrant it.
How De Novo works
A manufacturer submits a De Novo request demonstrating that the device provides a reasonable assurance of safety and effectiveness and that general and special controls can adequately mitigate identified risks. If granted, the FDA creates a new device classification (typically Class I or II) with specific regulatory controls. The De Novo device then becomes the first device of its type and can serve as a predicate for subsequent 510(k) submissions by competitors.
Strategic importance
De Novo is increasingly important for innovative medical technologies — AI/ML-based diagnostic tools, novel digital health devices, and combination products often use this pathway. In procurement, a De Novo classification signals an innovative device without direct competitors, which may affect tender specifications and evaluation criteria.