So they aren't predicting anything, are relying on manufacturers to self report, already have surprise shortages, and are monitoring and mitigating? These statutory authorities and responsibilities to assure blah blah blah, that doesn't give permission to prepare or ramp up requirements?
"Implementing critical infrastructure monitoring" is giving out an email address? Hmmm.
They're doing their job. My view is that bureaucracy has its own doublespeak for everything.
So when I see this:
> It is important to note that no law exists requiring medical device manufacturers to notify the FDA when they become aware of a circumstance, including discontinuation of a product, that could lead to a potential shortage, and manufacturers are not required to respond when the FDA requests information about potential supply chain disruption.
...in my head, I translate it to this:
> We welcome a law requiring medical device manufacturers to notify the FDA when they become aware of a potential shortage or discontinuation, and requiring manufacturers to respond when the FDA requests information about potential supply chain disruption.
"Implementing critical infrastructure monitoring" is giving out an email address? Hmmm.