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 EUAs
- Infusion Pump EUAs
- Personal Protective Equipment EUAs
- 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 EUAs
- Respiratory Assist Devices EUAs
- Ventilators and Ventilator Accessories EUAs
- Other Medical Device EUAs
