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Posted On: 03/25/2020 3:18:52 AM
Post# of 30066
FDA Emergency Use Authorizations
This page lists current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
In Vitro Diagnostics EUAs
On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to this public health emergency. This guidance was updated on March 16, 2020.
CDC has granted a right of reference to the performance data contained in CDC's EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.
The templates for these EUA submissions are available:
"Accelerated" Template for Laboratories Certified to Perform High-Complexity Testing Under CLIA: EUA Template(Updated March 7, 2020)Test Kit Manufacturer: EUA Template (Updated March 12, 2020)
https://www.fda.gov/medical-devices/emergency...orizations
This page lists current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
In Vitro Diagnostics EUAs
On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to this public health emergency. This guidance was updated on March 16, 2020.
CDC has granted a right of reference to the performance data contained in CDC's EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.
The templates for these EUA submissions are available:
"Accelerated" Template for Laboratories Certified to Perform High-Complexity Testing Under CLIA: EUA Template(Updated March 7, 2020)Test Kit Manufacturer: EUA Template (Updated March 12, 2020)
https://www.fda.gov/medical-devices/emergency...orizations
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