I am seeing a lot of new "faces" on the RAP threads, which is great. Media and broker reports will start to flow now which will bring in new retail and soon new institutional investors.
So, just to re-cap on what how the FDA goes about their business.
Clearly, the FDA may either grant or decline a De Novo request, but it seems highly probable to me which way they will go...and that is before you consider the current government initiative which favours new/disruptive technologies that decrease the cost of mass healthcare.
Grant
If your data and information demonstrate that general controls, or general and special controls are adequate to:
Provide reasonable assurance of safety and effectiveness, and
The probable benefits of the device outweigh the probable risks,
Then the FDA intends to grant the De Novo request and establish a new classification regulation for a new device type.
Decline
The FDA will decline a De Novo request if we determine that:
General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device;
The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device;
The probable benefits of the device do not outweigh the probable risks.
