The De Novo application is used by a medical device manufacturer that wants to market a completely new product that does not yet have a determined classification. The submission will allow the assessment and classification of the device as a Class I or Class II device – instead of automatically classifying it as Class III (due to legacy safety measures), the highest risk class, which may not be correct.
This submission type aims at accurately classifying a medical device, an in vitro diagnostic, or a medical software.
How does structured content authoring help?
The process of authoring and reviewing a De Novo application is prone to error. The review process is extensive, and it involves various departments inside or outside the medical device manufacturing organization.
Having all authors and reviewers work with structured content can help the organization reduce time-to-market for the product by making the document creation process more efficient. The structured authoring tool can be used to work collaboratively, concurrently, online and it eliminates the need to work with various printed or digital versions of documents spread out across emails, editing software, or repositories.