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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
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          Medical Device Safety
          Emergency Situations (Medical Devices)
          Emergency Use Authorizations for Medical Devices
          COVID-19 Emergency Use Authorizations for Medical Devices
          Continuous Renal Replacement Therapy and Hemodialysis Devices EUAsCOVID-19 Emergency Use Authorizations for Medical Devices Continuous Renal Replacement Therapy and Hemodialysis 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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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?


Continuous renal replacement therapy (CRRT) devices are used to filter and clean the blood when kidneys are damaged or not functioning normally. Based on published data, it has been noted that SARS-CoV-2, the virus that causes COVID-19, has led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. Devices authorized by these EUAs include the hemodialyzer/hemofilter, delivery unit, bloodlines and tubing, and dialysate solution.

The table below lists the authorization information for the use of specific CRRT and hemodialysis 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 Documents04/30/2020
			Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions
			QLP
			Healthcare Providers
				Patients
			Instructions for Use, Bloodline/Tubing
				Instructions for Use, UltraFlux
				Instructions for Use, multiFiltratePRO
				Summary of Product Characteristics (SmPC)
				Instructions for Use, MultiPlus05/20/2020
			Baxter Healthcare Corporation, Prismaflex ST Set
			QLP
			Healthcare Providers
				Patients
			Prismaflex ST Set - IFU - Global
				Prismaflex ST Set - IFU - South Korea
				Prismaflex ST Set - IFU - China08/10/2020
			Baxter Healthcare Corporation, Prismaflex HF20 Set
			QLP
			Healthcare Providers
				Patients
			Prismaflex HF20 Set - IFU
				Prismaflex HF20 Set - IFU Insert

                                                                                  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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