A de Novo is a classification process using a risk-based strategy for new, novel devices that have not been classified as of yet. The new ruling in 2014 streamlined the process by creating an alternative pathway that does not require submission of a 510k prior to a de novo request. Prior to this ruling, companies would have to submit a 510k, FDA would review it, and if they determined that the device had no substantial equivalent, they would automatically classify it as Class III, and the company would have to submit a de-novo application to try to have it down classified. Now companies can go directly to a de-novo application.

I think this new ruling makes sense, because the old process appeared to be extremely cumbersome and time consuming. For companies who are developing novel devices that do not have a predicate and that they believe should receive a Class I or Class II designation, this seems like an attractive regulatory route.

References:
https://www.fda.gov/downloads/training/cdrhlearn/ucm421766.pdf
https://www.meddeviceonline.com/doc/secrets-of-the-de-novo-pathway-part-why-aren-t-more-device-makers-using-it-0001