The De Novo Review Pathway classifies novel devices for which general and/or specific controls provide assurance of safety and effectiveness for the intended use, but for where there is no predicate device. This is as an alternative pathway to classify devices that would otherwise be Class III after receiving an not substantially equivalent (NSE) to be considered for Class I/II. The submission process has two pathways for devices of low to moderate risk: 510(k) to De Novo, or a Direct De Novo.
You can submit a De Novo request when your device satisfies the standards of a Class I or II device and when there are no existing predicate devices or regulations for your device. Additionally, it is eligible when a not substantially equivalent (NSE) was provided due to technological characteristics that change the safety and effectiveness or due to new intended use statements.
