De Novo Classification
/ˌdiː ˈnoʊvoʊ ˌklæsɪfɪˈkeɪʃən/
Definitions
- (n.) A regulatory process where the FDA classifies a medical device as low to moderate risk when no legally marketed predicate device exists, allowing the device to enter the market through a new evaluation pathway.
The company sought a de novo classification for its innovative medical device lacking a predicate.
Forms
- de novo classification
- de novo classifications
Related terms
See also
Commentary
De novo classification is a distinct FDA regulatory route, offering a simpler pathway compared to premarket approval, applicable only when no substantially equivalent device exists.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.