FDA recent Townhall21 Apr 2021 22:14
This is very interesting to read , especially towards the end.
“ Okay. So, you know, to clarify the high throughput is really because, you know, that will help increase the testing capacity which is, you know, what is needed at this stage for, you know, as we try to get more routine testing done...
Right.
...through routine testing programs. Kris Do you want to talk about the validation that we would look for there?
Sure. Yes I think, you know, if the test is going to be distributed with a high throughput workflow, you know, that’s the workflow that should be validated. You know I think performance in a 96 wheel just for instance performance in a 96-wheel plate may be different than a 3-to 4-wheel plate right? Heat transfer is different. Optimal characteristics perhaps are different. So I guess what we don’t want to see is, you know, like a manual workflow done in the, you know, validation. And then, you know, kind of maybe just an LOD study or something, like, that to validate the high throughput.
I think what we want to see is that the high throughput solution is kind of producing, you know, acceptable results because, you know, that’s really the solution that’s going to impact, you know, testing the most.”
Link:
https://www.fda.gov/media/147771/download