A de Novo approach is efficient in getting the approval from the FDA and launching the products in the market rapidly. It’s used for new devices that has not been previously classified by the FDA. FDA uses a risk-based strategy to classify the device into Class I or II. New ruling of de novo process has streamlined the entire process by making it easier for the medical device sponsor to get an approval without the submission of 510k approval. If the de Novo application is granted, then it establishes a new device with the necessary controls and classification regulation. Also, the device is eligible to be marketed and used as predicate for future medical devices and 510k approval. All in all, this new ruling of the de novo 510k process make it efficient for the sponsor and the future company to release and market the product.