After over-regulation of PCR tests leading to the flawed CDC test being the only one available during a critical part of the pandemic, the agency decided to swing way way way too hard the other way so they couldn't be accused of holding up tests from reaching the market. This whole fiasco has revealed the importance of modernizing the FDA (they still need documents to be sent by CDs in the mail![1]). And, of proactively creating pandemic response protocols. They're a healthcare agency! This is their job! The failure of the federal government has been so profound. At least it'll make a good case study for what not to do...
[1] https://www.washingtonpost.com/investigations/2020/04/03/cor...