Vivos Inc (RDGL)

[kheath39]

What are the pathways for De Novo submission?

There are two De Novo process pathways that can assist in obtaining a reclassification of your novel device.

The first option is the pre de novo submission (PDS). The PDS involves early-stage discussions with FDA reviewers to determine whether your device is a good de novo candidate, as well as which materials you should provide to the FDA as part of your de novo petition.
The second option is a standard 510(k) submission resulting in a not substantially equivalent (NSE) decision by FDA reviewers. Following the NSE, you have 30 days to submit a de novo petition.

Here is the problem "investors" from last year had. Jim FAILED to submit within 30 days. He was so busy it took 10 months. Lots of paperwork came across his desk I guess.

Anybody have an answer about this?