Newsletter - December 2, 2021
If You Ever Wanted to File a FOI Request with FDA: Forget it.
For those who have tried, sending a Freedom of Information (FOI) request to FDA is like dropping a coin in a wishing well and then hoping for your prayers to be answered. FDA recently provided a rare glimpse into its FOI process in response to a court case and it would come as no surprise as to why FDA is so...Read More
Did the EUA for Covid Tests, Kill the 510k for them?
Why is there only one diagnostic test for Covid cleared by FDA under the 510k pathway after almost 2 years of the pandemic? FDA has granted emergency use authorizations (EUA) to 423 Covid tests, but it has only given one device 510k clearance, that too in March of this year, 9 months ago...Read More
If You Ever Wanted to File a FOI Request with FDA: Forget it.
For those who have tried, sending a Freedom of Information (FOI) request to FDA is like dropping a coin in a wishing well and then hoping for your prayers to be answered. FDA recently provided a rare glimpse into its FOI process in response to a court case and it would come as no surprise as to why FDA is so...Read More
Did the EUA for Covid Tests, Kill the 510k for them?
Why is there only one diagnostic test for Covid cleared by FDA under the 510k pathway after almost 2 years of the pandemic? FDA has granted emergency use authorizations (EUA) to 423 Covid tests, but it has only given one device 510k clearance, that too in March of this year, 9 months ago...Read More
