Understanding the De Novo process
https://www.rcri-inc.com/understanding-de-novo-medical-device-classification-process/
What is the De Novo Classification Process?
The De Novo classification process, also known as “Evaluation of Automatic Class III Designation,” is a device classification process that allows FDA to classify new devices that are not equivalent to an existing Class I or Class II device and would otherwise be automatically classified as a Class III device [Section 513(f)(1 ) of the FD&C Act)], regardless of the device risks or the ability to demonstrate general or special controls.
Another site
http://www.thefdagroup.com/thefdgroup-blog/2015/08/what-is-a-de-novo-classification/
- Forums
- ASX - By Stock
- nuh media thread
Understanding the De Novo process...
-
- There are more pages in this discussion • 8,473 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add NUH (ASX) to my watchlist
|
|||||
Last
8.1¢ |
Change
0.000(0.00%) |
Mkt cap ! $21.91M |
Open | High | Low | Value | Volume |
0.0¢ | 0.0¢ | 0.0¢ | $0 | 0 |
NUH (ASX) Chart |
Day chart unavailable
The Watchlist
SER
STRATEGIC ENERGY RESOURCES LIMITED
David DeTata, Managing Director
David DeTata
Managing Director
SPONSORED BY The Market Online