Compliance
De Novo
de novo classification
TL;DR
FDA pathway for novel low-to-moderate-risk devices with no predicate — establishes a new classification rather than going straight to PMA.
Created in 1997 and streamlined by FDASIA 2012, the De Novo pathway lets a sponsor of a novel device, where no predicate exists, request that FDA classify it as Class I or Class II based on the actual risk profile. Once granted, the device itself becomes a predicate for future 510(k) submissions.
De Novo is the route most modern AI / software-as-a-medical-device (SaMD) products take. V5 supports the design-history evidence and software lifecycle (IEC 62304-aligned) needed for De Novo.
Regulatory anchors
- FD&C §513(f)(2)
Want to see De Novo in V5?
Free trial, no credit card, onboard in days, not months.