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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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


This page lists EUAs not described in any of the other pages in the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices Section.

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

Date EUA Issued
			Device Type
			Letter of Authorization
			Fact Sheets
			Other Documents
			Assigned Product Code03/15/2023
			LVEF Screen
			Anumana Inc, ELEFT
			Healthcare Providers
				Patients
			IFU
			QLL05/26/2020
			Predictive Screening
			CLEW Medical Ltd.
			Healthcare Providers
				Patients
			IFU
				Letter Granting EUA Amendment(s) (June 30, 2020)
			QLM05/29/2020
			Right Ventricular Assist Catheter
			Abiomed, Inc., Impella RP System
			Healthcare Providers
				Patients
			IFU
			QOC04/18/2020
			Face Mask (non-Surgical)
			Face Mask (non-Surgical)
			
			Face Mask EUA FAQ
			QKR08/03/2020
			Left Ventricular Support System
			Abiomed, Inc., Impella LV Systems
			Healthcare Providers
				Patients
			IFU - Impella Ventricular Support System 2.5, CP, 5.0, and LD
				IFU - Impella Ventricular Support System 5.5
				IFU - Impella Ventricular Support System CP
			QOC09/24/2020
			Predictive Screening
			COVIage
			Healthcare Providers
				Patients
			IFU
			QLM11/21/2020
			Extracorporeal Membrane Oxygenation
			Terumo Cardiovascular CAPIOX Emergency Bypass System
			Healthcare Providers
				Patients
			IFU
			QOD03/19/2021
			Symptom Screening Tool
			Tiger Tech Solutions, Inc., Tiger Tech COVID Plus Monitor
			Users
				Recipients
			IFU
			QOA

                                                                                  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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