An IDE application got a reviewer question from the FDA within days of submission, skipping the usual document control step. A CEO's low-risk device is being fast-tracked, suggesting the FDA is prioritizing quick wins on simpler submissions to show it's moving faster.
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I have one little piece of good news as far as all this stuff goes. Submitted an IDE application on Monday and then yesterday got a question back from FDA, which I hadn't expected because I didn't know who was left there. I wasn't even sure they're going to be able to acknowledge, you know, that it came in because they did get rid of the entire document control, you know, the incoming document control section. So that may have been automated, but I got, I got a response or, or, or a question from a reviewer. So, or they could just be operating a little bit more efficiently.
Yeah, that's another effect. Yeah, trying to hold on to that job, you know. I was talking to a CEO this morning and they're, uh, they're fast-tracking his device because it's low risk and I think they want to put up more wins in the column. At the FDA. So things that aren't scary, I think they're gonna go faster just to put points on the board.