primavesvera
Involved In Discussions
Hey, guys!
This is my first time preparing a special 510(k) and I went through all related topics and guidelines to find the things that are bothering me and I seem to be stuck on one particular - description of the modified device.
In the first submission (I wasn't working here back then), the company provided a device description containing basically everything, from intended use, requirements, risk analysis, testing, every single thing was there.
Now that I have to do a modification of the description of the device, I thought I would be appropriate to use the same document and only insert and highlight the changes.
Do you think this is FDA acceptable? Or is there some other way that I don't know?
Thanks in advance.
P.S. I am aware of the requirements from 807.78.
This is my first time preparing a special 510(k) and I went through all related topics and guidelines to find the things that are bothering me and I seem to be stuck on one particular - description of the modified device.
In the first submission (I wasn't working here back then), the company provided a device description containing basically everything, from intended use, requirements, risk analysis, testing, every single thing was there.
Now that I have to do a modification of the description of the device, I thought I would be appropriate to use the same document and only insert and highlight the changes.
Do you think this is FDA acceptable? Or is there some other way that I don't know?
Thanks in advance.
P.S. I am aware of the requirements from 807.78.