August 6, 2020
The content in this post is from the FDA website. We have observed a large number of EUA's this year and wanted to share the information with you.
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the disease COVID-19.
On the basis of this determination, the Secretary of HHS has subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for
the detection and/or diagnosis of COVID-19 (February 4, 2020), personal respiratory protective devices (March 2, 2020), and other medical devices, including alternative products used as medical devices (March 24, 2020), for use during the COVID-19 outbreak pursuant to section 564 of the Act and subject to the terms of any authorization issued under that section.
Also see PREP Act declaration: Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020). Get information on the Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices that CDRH has issued related to COVID-19:
Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
Individual EUAs for Serology Tests for SARS-CoV-2
Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
Individual EUAs for IVDs for Management of COVID-19 Patients
N95 and Other Respirators EUAs (including EUAs for NISOH-approved N95s and imported respirators)
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)Manufactured in China
Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
Face Shields and Other Barrier EUAs
As always, thanks for reading! Stay safe and be well!
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CEO and Principal Consultant