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
• Infusion Pump EUAs
• Personal Protective Equipment EUAs
• Remote or Wearable Patient Monitoring Devices EUAs
• Respiratory Assist Devices EUAs
• Ventilators and Ventilator Accessories EUAs
• Other Medical Device EUAs