FDA uses de novo system to classify medical devices as class I, class II, class III based on increasing risk to patient or user. The new devices are considered class III in the US, devices that are innovative sometime their exact predicate device is difficult to find so ‘Request for information ‘ that would outline characteristics of device would submitted to FDA called 513(g) submission . If FDA through 513(g) states that device has no existing classification or predicate device on market ,we can file “de novo” submission after that FDA will decide if device is entirely new, class I ,class II and issue regulation number .Device remains in class III if it is rejected It helps to determine proper classification and regulatory requirement for medical devices. The “de novo” process is intended to improve efficiency of bringing low risk medical device to market that was classified as class III due to absence of predicate devices through a simple reclassification of devices. Now, manufacturer no longer need to submit 510(K) and wait for decision of NSE. Before “de novo” manufacturer have no other option to PMA if no predicate exist . PMA is lengthy and costly. If device is novel , presenting medium or low risk profile and no predicates exists de novo is the right option.