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 In this section:

        Emergency Use Authorizations for Medical Devices

COVID-19 Emergency Use Authorizations for Medical Devices

                        
                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 Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)
          Emergency Use Authorizations for Medical Devices
          COVID-19 Emergency Use Authorizations for Medical DevicesEmergency Use Authorizations for Medical Devices COVID-19 Emergency Use Authorizations for Medical Devices
  	
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    PrintNovember 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the *Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.

The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: *Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)*, which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?


**COVID-19 Public Health Response Background**

The Secretary of the Department of Health and Human Services (HHS) issued a determination under section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act (initially issued February 4, 2020, and amended March 15, 2023), that there is a public health emergency, or a significant potential for a public health emergency, that affects, or 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 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 declared that circumstances exist justifying the authorization of emergency use of certain 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 FD&C 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).

On May 11, 2023, the COVID-19 public health emergency declared under section 319 of the Public Health Service (PHS) Act expired. The ending of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?

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 EUAsCOVID-19 Resources

COVID-19 and Medical Devices
	FAQs on Emergency Use Authorizations (EUAs) for Devices - COVID-19
	COVID-19 Frequently Asked Questions
	COVID-19 EUA Information from FDA
	FAQs on Testing for SARS-CoV-2
	Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
	Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
	Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023

                                                                                  Content current as of:
      11/08/2023
                  
                   
Regulated Product(s)
		 Medical DevicesHealth Topic(s)
			  CoronavirusCOVID-19 Emergency Use Authorizations for Medical Devices                
                          

                        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
 
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