FDA announces the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19)

FDA announces the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency.

In February 2020 the Food and Drug Administration (FDA) began issuing emergency use authorizations for certain in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices. 

Today the FDA issues Federal Register Notice 85 FR 74346 which contains emergency authorizations for 102 multianalyte tests, 37 Serology tests, 3 in vitro diagnostics and 24 medical devices.

Certain disposable filtering facepiece respirators as we all disposable, single-use surgical masks have been issued emergency use authorizations.  FDA has provided two lists of respirators models authorized by this EUA available here and here.  As well as a list of authorized surgical masks available here.

If we can provide any guidance, please contact Delmar US Advisory Services.

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