De Novo Authorization
Also called: De Novo classification, De Novo request
The FDA route for novel low-to-moderate risk devices with no existing predicate, which creates a new classification future devices can then cite.
When a device is genuinely new and no predicate exists, a 510(k) is impossible. De Novo allows the FDA to authorize it and simultaneously create a classification with special controls. Later similar devices can then use it as a predicate and take the 510(k) route.
Most of the notable firsts in medical AI went through De Novo: the first autonomous diagnostic, the first triage device, the first authorized pathology AI, the first real-time endoscopy detection device.
Where This Gets Misread
De Novo is a heavier lift than 510(k) but lighter than premarket approval, and it is frequently reported as though it were the strictest route. It is not. Its significance is that it opens a category, which is why the second device of a given type usually reaches market far faster than the first.