All terms
De Novo Classification Request
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
The De Novo classification process provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide a reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.What this means in practice
Granting a De Novo creates a new device classification and can serve as a predicate for future 510(k) submissions, shaping the regulatory framework for an entire device category.Use cases
1 scenario1
First-of-kind continuous glucose-trend wearable
Regulatory strategistA wearable measures interstitial glucose trends but doesn't fit any existing product code. The sponsor receives a Not Substantially Equivalent decision on a 510(k), then files a De Novo with risk-based special controls.
OutcomeFDA grants De Novo classification as Class II and creates a new product code, which becomes a predicate for future entrants.
Cross-references
Often confused with
Distinct concept frequently mistaken for this one.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
FDA·1IMDRF·1RAPS·1
- 1
De Novo Classification RequestVerifiedFDAfda.gov
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.