Have you like many others, been pondering why it’s been so hard to ramp up production of surgical masks and respirators and are curious as to why private companies haven’t flooded into the market to meet peak demand?
Well, Paul Matzko, author of “The Radio Right” (Oxford, May 2020), and Assistant Editor for Tech & Innovation at The Cato Institute, has some answers in a brief Twitter-thread:
TL;DR: Because they are regulated medical devices & new versions require FDA approval which can take months to obtain.
Take a look at this FDA regulation, intended to ease (!) the application process for “premarket notification.” That means you have to do all of this – and get FDA sign off – before your new surgical mask gets anywhere near shelves.
