The DeNovo Classification process has yet to be established in the regulations, though it was added to the FD&C Act in 1997 and further updated in subsequent amendments. A proposed rule for the DeNovo process was published in early December 2018 and will be open for public comment until 07MAR2019. The De Novo process provides a pathway to classify novel medical devices that have a risk-based classification of Category I or II but for which there is no legally marketed predicate device. A device classified as Category I or II through the DeNovo process may then be used as a predicate device for other future devices. 

DeNovo requests may be triggered by one of two events:

1. A sponsor receives a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. The NSE should be for a device with a new intended use or different technological characteristics from the proposed predicate device that raise questions of safety and effectiveness.
2. When a sponsor determines there is no legally marketed predicate device (without submitting a 510(k) and receiving an NSE determination).

The agency recommends sponsors consider using the Pre-Submission program to obtain feedback prior to submitting a DeNovo request. The request has specific requirements and timelines which are outlined on the program’s web page. 

Granting of the DeNovo request triggers the following events:

• The new device is legally marketed and must be in compliance with applicable regulatory controls;
• A new classification regulation is established;
• The new device may now serve as a predicate device for 510(k) submissions of future devices of the same type;
• The FDA publishes in the Federal Register a notice that announces the new classification regulation and, for class II devices, the new special controls;
• The FDA posts on its website a copy of the granting order notifying the sponsor that we have granted marketing authorization; and
• The FDA generates and publicly discloses a decision summary.

Information about granted DeNovo requests is available in the De Novo Classification Requests database and also on the website Evaluation of Automatic Class III Designation (De Novo) Summaries. Review of granted requests may be helpful in preparation of new requests.

 Text Copyright © 2019 Katrina Rogers