So, I was still up at 2am – again – trying to wrap my brain around the latest changes to the EUA process for surgical masks. 🥱
Reason and good sense had clearly departed for the evening, because I thought – I need to make a video! Right now! 😳
This latest change is a significant one, because it puts the EUA approval requirements almost on par with a full 510(k) submission.
Yes, you read that correctly. Only one validation test now differentiates the EUA and 510(k) approval processes for masks.
So, excuse the hat, and the false start, and the gravelly voice (did I mention it was two am?) and make note of these changes, because they could impact the availability of masks at some point.
If you need me, I’ll be sleeping. Or trying to.