When the De Novo process was first initiated, sponsors needed to submit the premarket notification (510(k)), to which the FDA would issue final 510(k) decision of “not substantially equivalent” due to no predicate. The sponsor would then need to submit A De Novo request and the FDA would decide whether to classify device from Class III to Class I or II with new classification/regulation. The revision of 2014 allowed alternative pathway that doesn’t require submission of a 510(k) prior to de novo request limiting the timeframe for review set at 120 FDA days. This revision of the De Novo process is highly attractive because it is less cumbersome and time-consuming. It provides companies with a direct regulatory pathway toward a Class I or Class II designation.