Understanding the De Novo process...

Understanding the De Novo process

https://www.rcri-inc.com/understanding-de-novo-medical-device-classification-process/

What is the De Novo Classification Process?
The De Novo classification process, also known as “Evaluation of Automatic Class III Designation,” is a device classification process that allows FDA to classify new devices that are not equivalent to an existing Class I or Class II device and would otherwise be automatically classified as a Class III device [Section 513(f)(1 ) of the FD&C Act)], regardless of the device risks or the ability to demonstrate general or special controls.

Another site

http://www.thefdagroup.com/thefdgroup-blog/2015/08/what-is-a-de-novo-classification/