De Novo is a classification process which uses a risk based strategy for new novel devices whose types has not previously been classified. It can be used for devices that would have been classified into Class III to allow them to be classified into Class I or II. For the De Novo process an application must be sent to the FDA, and if it is granted would establish a new “device type” along with classification, regulation, and necessary controls and product code.
A 510(k) submission is not needed before a device is submitted for the De Novo application process. However pre-submissions are strongly recommended prior to the submission of de novo, especially devices that have not been previously reviewed under a 510(k).
In my opinion it is good to have a process like De Novo which allows a certain amount of flexibility to the classification process and does not require additional unnecessary regulations on medical devices that are not needed. By being able to be flexible on medical device classifications, it allows medical devices companies to be able to develop and release products faster for products that would have been rigidly classified into a high medical device class. Using a risk based approach for the classification is the best way to do this in my opinion as it maintains the integrity of the safety for the end users of all medical devices which are sold.