Re: When is a system not a single device?
How long ago did you submit this to FDA?
jewels said:
Yes, I know. The statement received was:
"the "kits" do not have the same intended use. Therefore, we cannot list both of them on the same license." The intended use was very similar and still they did not consider them the same device.
I did challenge it and the outcome was to list them on 2 licenses.
That's why my previous comment was to ask the agencies what they will expect to avoid delay in getting the license accepted.
"the "kits" do not have the same intended use. Therefore, we cannot list both of them on the same license." The intended use was very similar and still they did not consider them the same device.
I did challenge it and the outcome was to list them on 2 licenses.
That's why my previous comment was to ask the agencies what they will expect to avoid delay in getting the license accepted.