A De Novo request is suitable for novel, low-to-moderate risk devices without a predicate, where safety and effectiveness can be assured through general and/or special controls. Early FDA engagement helps confirm eligibility.
A De Novo classification request is appropriate when your device has no legally marketed predicate and the FDA can achieve a reasonable assurance of safety and effectiveness through general controls alone or together with special controls. This pathway reclassifies an “automatic Class III” device to Class I or II, enabling market entry without a Premarket Approval (PMA).
The electronic Code of Federal Regulations (eCFR) codifies acceptance conditions and content expectations for De Novo requests. These include:
If the FDA finds a suitable predicate exists or risks cannot be mitigated by special controls, the De Novo request may be declined, redirecting you toward the 510(k) or PMA pathways. Early FDA interaction can help derisk this outcome.
Use a PreSub meeting to confirm your device’s eligibility for De Novo classification, discuss risk mitigations, and verify whether the FDA views your device as a candidate for Class II special controls. Early engagement helps clarify expectations and smooth the regulatory pathway.
