FDA has developed this guidance document to assist industry in preparing premarket notification submissions for surgical masks and other masks.
fda.gov
Let's say that you're a garment manufacturer in NYC, but, of course, retail sales are down, so you're looking for another revenue stream. Why not make surgical masks, keeping your doors open, employees employed, and saving lives? It's a win-win-win! 3/
But how long do you think it would take you to jump through these hurdles, and do you think someone without an army of regulatory compliance officers would be reasonably able to do so at all? 4/
To start, you must:
- do a compositional side-by-side analysis of your mask vs all other masks currently sold. Hire a few materials scientists, okay.
- measure "tensile strength" & "impact resistance." Hire the Mythbusters and have them whack it with a hammer.
- perform detailed "risk analysis," for fluid/bacteria resistance and "flammability." Hmmm, better open a branch office for all those extra materials scientists and medical researchers. This is multiple major studies (though a Boring Company flamethrower might work in a pinch.)
- but wait, don't forget that masks touch skin! What if it gives you a rash!!! Okay, fine, we'll fill out the "standard ISO-10993," yeah, you know, the one for “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Sprinkle in a couple more clinicians.
I could go on and on. There is no world in which any company not already deeply invested in manufacturing surgical masks could jump through these hurdles in time to mitigate the desperate shortage of PPE for medical professionals on the COVID-19 front lines. None.