As I have said before, there is nothing simple about a surgical mask.
And now many companies seeking to manufacture or import surgical masks are finding that what they thought was a “simple” mask is actually subject to some very complex and detailed regulations.
To their dismay, they are also realizing that the EUA process is not an open ticket to market success. Or a get out of jail free card. 😉
In this video, I take a deep dive into the FDA regulatory wormhole, using masks as my example. There is also a brief foray into the EUA wormhole and some insight from a few knowledgeable friends, just to keep things interesting. Enjoy!
Here’s another video on FDA submission pathways: https://youtu.be/n8W7CM_OG24
Have another medical device to bring to market? We can help: https://leanraqa.com/industries/medical-devices/