De Novo classification process involves new, novice unclassified devices using a risk based strategy to determine their class; class I, II or III. An application drafted by Medical Device Sponsor is sent to FDA to determine device type along with classification, regulation, necessary controls and product code if accepted.

De Novo 510K is the submission process of 510k by manufacturer, reviewed by FDA for lack of predicates. Sponsor also submit De Novo to be regulated for lack of evidence to demonstrate safety and effectiveness of new device. And reviewed by FDA for application acknowledgement or rejection.

Under regulatory structure, De Novo fits under Premarket Notification 510(k) which demostrate to be a predicate device and CDRH Class 1,2.