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:
- Blood Purification Devices EUAs
- Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
- In Vitro Diagnostics EUAs
- 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