De Novo

De Novo classification is an FDA regulatory pathway for novel medical devices that are low-to-moderate risk but have no legally marketed predicate device. The term "De Novo" means "from the beginning" in Latin, reflecting that these devices are creating a new device classification.

When to use De Novo:
- Device is novel with no substantially equivalent predicate
- Device is low-to-moderate risk (appropriate for Class I or II)
- Device would otherwise default to Class III due to lack of predicate
- 510(k) pathway is not available

De Novo process:
1. Submit De Novo request with performance data
2. FDA reviews for safety and effectiveness
3. FDA creates new device type and classification
4. Device becomes predicate for future 510(k)s

Key requirements:
- Comprehensive performance testing data
- Proposed classification (Class I or II)
- Proposed special controls (for Class II)
- Risk analysis and mitigation measures
- Labeling and intended use

Timeline and fees:
- FDA review goal: 150 days (but often longer)
- User fees apply (similar to 510(k) fees)

Strategic advantage: A successful De Novo creates a new device classification and makes your product the predicate. Competitors must then file 510(k)s against your device, giving you first-mover advantage.

Examples of De Novo devices:
- First continuous glucose monitors
- Novel AI/ML diagnostic devices
- Innovative wearable devices