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 In this section:

                COVID-19 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 Devices
          Blood Purification Devices EUAsCOVID-19 Emergency Use Authorizations for Medical Devices Blood Purification Devices EUAs
  
  	
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    Print**November 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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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)* and *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?


Blood purification devices may be effective at treating certain patients with confirmed COVID-19 by reducing various pathogens, cytokines, and other inflammatory mediators, that is, small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that may occur in some COVID-19 patients, potentially leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.

The table below lists the authorization information for the use of specific blood purification devices during the COVID-19 public health emergency.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

Date EUA Issued
			Letter of Authorization
			Assigned Product Code
			Fact Sheets
			Other Documents04/09/2020
			Terumo BCT Inc. and Marker Therapeutics AG Extracorporeal Blood Purification (EBP) Devices
			QLO
			Healthcare Providers
				Patients
			Operation Manual for Use of D2000 with the Spectra Optia Apheresis System
				Spectra Optia Apheresis System Operator's Manual
				D2000 Cartridge IFU04/10/2020
			CytoSorbents, Inc. Extracorporeal Blood Purification (EBP) Device
			QLO
			Healthcare Providers
				Patients
			IFU04/17/2020
			ExThera Medical Corporation Extracorporeal Blood Purification (EBP) Device
			QLO
			Healthcare Providers
				Patients
			IFU04/22/2020
			Baxter Healthcare Corporation Extracorporeal Blood Purification (EBP) Device
			QLO
			Healthcare Providers
				Patients
			IFU

                                                                                  Content current as of:
      11/08/2023COVID-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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