CDRH Launches New COVID-19 EUA Web Section

Recently the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new web section “Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices” to help make it easier for the public to access this information. When the web section launched, new web pages and, therefore, new web addresses were created for each category of device emergency use authorizations (EUAs).

This new web section provides information on the EUAs issued for diagnostic and other medical devices during the COVID-19 outbreak on individual pages as listed below:

Blood Purification Devices
Continuous Renal Replacement Therapy and Hemodialysis Devices
In Vitro Diagnostics
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
Decontamination Systems for Personal Protective Equipment
Infusion Pump
Personal Protective Equipment
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
Remote or Wearable Patient Monitoring Devices
Respiratory Assist Devices
Ventilators and Ventilator Accessories
Other Medical Device