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Re: chxal post# 6252

Thursday, 09/24/2020 10:17:57 AM

Thursday, September 24, 2020 10:17:57 AM

Post# of 14946
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

You mentioned a date from June in your post no? That is the date you re using for your expectations for an EUA. I have post twice now that the goal posts have been moved. I know trust but verify.

IF you scan down to the template posting dates you should see July 28th.
Now do the 6-8 weeks from then but don't forget to add the time that it would take to aquire/meet the new requirements.
IF we had all the data already that we are at the end of the 8 week window. IF we didn't than we are probably still a couple of weeks away before we should expect an update for the EUA.
If we have nothing by the end of Oct. we all should be shouting from the top of our lungs ok?

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