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The End of the COVID-Era EUAs

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Manage episode 340317932 series 2446473
Content provided by RAQA Today and Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RAQA Today and Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
The end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next? Earlier in the year, the FDA laid out their proposed plans for transitioning devices marketed under and EUA or FDA enforcement policy - then went radio silent. They still haven't released their final guidance, so what's a manufacturer to do? In this podcast, we'll review the proposed FDA recommendations, suggest the type of feedback industry should provide to the FDA, and discuss actions to take if you are a manufacturer with an active EUA. In other words, we'll laugh, we'll cry, we'll rail at the insanity that has been the entire EUA process. 😁
  continue reading

44 episodes

Artwork
iconShare
 
Manage episode 340317932 series 2446473
Content provided by RAQA Today and Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RAQA Today and Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
The end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next? Earlier in the year, the FDA laid out their proposed plans for transitioning devices marketed under and EUA or FDA enforcement policy - then went radio silent. They still haven't released their final guidance, so what's a manufacturer to do? In this podcast, we'll review the proposed FDA recommendations, suggest the type of feedback industry should provide to the FDA, and discuss actions to take if you are a manufacturer with an active EUA. In other words, we'll laugh, we'll cry, we'll rail at the insanity that has been the entire EUA process. 😁
  continue reading

44 episodes

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