Just over a year after COVID-19 put the world on hold, the powers that be have released a news brief in which the FDA puts a positive spin on 2020.
We knew this was coming….it was just a question of when.
As we enter the second year of the pandemic, the agency’s regulatory spin doctors are hard at work trying to paint their 2020 performance in a rosy light.
Don’t get me wrong – no one’s going to argue that the agency wasn’t busy.
Between the record-setting number of new device submissions and the equally impressive number of EUA applications, we can all agree that CDRH held on by the skin of their very teeth last year.
And that’s without their usual jam-packed schedule of onsite inspections, which the FDA temporarily halted in favor of remote inspections in certain, non-urgent situations.
But this still made me chuckle:
“First and foremost, we have adopted agile, interactive and innovative approaches to EUA review, publishing 13 “EUA templates” that have been revised 11 times to help clarify the agency’s expectations to streamline review, where possible.”
You all know that I experienced this first-hand as part of the Great Surgical Mask Disaster of 2020, as the agency changed their testing requirements for EUA submission. And then changed them again.
But does that mean they didn’t really know what they wanted in the first place? That’s sure how it reads to me.
I understand that COVID management was (is?) a fluid thing as more information and data became available, but touting the fact that you revised your templates 11 times seems an odd way to instill faith in your organization.
That being said, I fully expect the next article in which the FDA puts a positive spin on 2020 to be just as amusing a read as this one.
Check out the full article on the FDA site: https://www.fda.gov/news-events/fda-voices/year-pandemic-how-fdas-center-devices-and-radiological-health-prioritizing-its-workload-and-looking
Looking for still more interesting tidbits about the FDA? Check out my blog: https://leanraqa.com/blog/