The De Novo pathway for device marketing rights was introduced to address novel devices of low-to-moderate risk that do not have a predicate device. Although it is has gained in popularity, the De Novo pathway has been around since 1997. De Novo classification is a risk-based classification process. Manufacturers with novel devices of low-to-moderate risk have two options when considering the De Novo pathway. Option 1: the company can submit a 510(k) to FDA, and upon receipt of a Not Substantially Equivalent determination, the De Novo request can be made; or Option 2: Upon finding that there is no predicate, the company can then submit a De Novo request without first submitting a 510(k) and receiving a high-level not substantially equivalent determination. Devices that are classified into class I or class II through a De Novo request may be marketed and used as predicates for future notification 510(k) submissions.
A De Novo request must include all the document requirements as listed in the Acceptance Review for De Novo Classification Request guidance. Prior to submitting a De Novo Request manufacturers are advised to consider submitting a pre-submission to attain feedback from the appropriate premarket review division. Upon successful review of a De Novo submission, FDA creates a classification for the device, a regulation if required, and ascertains any special controls required for future premarket submissions of substantially equivalent devices. The FDA has the right to refuse-to-accept a De Novo request that does not include these elements.