De Novo request

De Novo is the route for novel low-to-moderate risk devices that cannot use a 510(k). Once granted, the device can serve as a predicate for future 510(k)s, and the order creates a new classification regulation with special controls.

De Novo request means any submission under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act for a medical device, requesting classification into class I or class II, including all information submitted with or incorporated by reference therein.

21 CFR, 860.3