The De Novo pathway is for low- to moderate-risk devices that have no existing predicate and are therefore not eligible for a 510(k). This process allows novel devices to be classified as Class I or II based on a risk-based assessment, rather than being automatically designated as high-risk Class III.
Use the De Novo pathway when:
- Your device is novel and not substantially equivalent to any existing marketed device.
- You can demonstrate, through nonclinical and/or clinical data, that the device is safe and effective for its intended use.
- The device poses low to moderate risk that can be mitigated through general or special controls.
Once a De Novo is granted, your device can serve as a predicate for future 510(k) submissions.
