US FDA De Novo Classification Pathway
For novel or higher-risk devices, we build the regulatory strategy around the evidence FDA will need to reach a classification or approval decision, integrating risk, controls, non-clinical evidence, clinical evidence and FDA interaction.
What These Pathways Are
De Novo is a classification pathway for certain novel devices where no suitable predicate exists and the risks can be addressed through appropriate controls. PMA is the premarket approval pathway for applicable Class III devices requiring a higher level of evidence to demonstrate safety and effectiveness.
When De Novo May Be Appropriate
- No appropriate legally marketed predicate exists
- The device is novel but may be suitable for Class I or Class II controls
- Risks can potentially be mitigated through general and/or special controls
- FDA interaction is needed to clarify classification or evidence expectations
When PMA May Be Required
- The device is Class III and subject to PMA requirements
- The device presents a higher risk profile requiring more extensive evidence
- Clinical evidence and manufacturing controls form a central part of the approval decision
How We Support the Strategy
Integrated Regulatory Decision Architecture
For De Novo and PMA, we do not treat risk, testing, clinical evidence, labeling and manufacturing as separate workstreams. We align them around the regulatory decision FDA ultimately needs to make.
Pathway Comparison
De Novo Pathway
Creates a brand-new classification & product code for future 510(k) predicates.
PMA Pathway
Requires rigorous clinical trial evidence & pre-approval FDA facility inspection.
Novel Device Strategy?
Establish whether your device qualifies for De Novo classification instead of a full PMA.
Discuss Novel StrategyPioneering a Novel Medical Device in the US?
Our senior strategists design robust De Novo and PMA submissions that establish clinical efficacy and regulatory leadership.