FDA De Novo approval date for Painchek's Dementia App, page-4

I haven't spent a lot of time researching, but from the little time I have it's been hard to piece together the de novo pathway options. FDA website doesn't seem to have much info publicly available.

Can't paste on phone but have found a website emergobyul.com if you search that plus fda de novo. Talks to the pre submission being about establishing the class of the medical device - class I or class II. It also says that pre submission may result in a de novo rejection so the device remains class III, or a new classification (who knows what that means).

The different classes are based on reliability, risk factors etc. From memory the requirements increase as the class number increases.

The main comparison to remember between pck and rap are that pck is a diagnostic tool, where resapp is a diagnosis tool. Different, and more risk factors with the later. Time will tell if both are classified the same. There is a chance that, for example, pck is classified as class I and rap class II. The class will also influence the need for local US trials or simply acknowledgement of existing clinical/commercial data as evidence.

Others may have more to add based on their own research.