According to the FDA update from November 2014, the de novo is a sorting process that categorizes novel devices based on risk strategy. It is similar to the regulatory structure that we identify with in terms of class I, II or III. Based on the medical device amendment of 1976 the medical device classification will result in certain controls and documentation. Such as the premarket approval for class III devices. The de novo is also known as “evaluation of automatic class III designation.” In 2012 the process was changed to exempt a 510 k submission prior to the de novo request with a set 120 FDA day review.
De Novo is first approached when an application is sent from the medical device company to the FDA.

The two outcomes of submitting this application are:
1. Classify the new medical device along with the controls and product code
2. If the device is similar to previous devices then a 510 K will need to be completed

The process has two submission pathways:
1. Complete a 510 k then complete a de novo
2. Complete a de novo directly

If a de novo is granted then the new device is legally marketed and the establishment of a new classification regulation must be completed.

References:
https://www.fda.gov/downloads/training/cdrhlearn/ucm421766.pdf
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm