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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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


Respiratory assist devices include devices intended to help patients in need of support for breathing, removal of carbon dioxide, and therapy to reduce disuse atrophy of abdominal wall muscles. The FDA has issued EUAs to help increase the availability of respiratory assist devices, which are integral to treat patients during the COVID-19 pandemic.

The table below lists the respiratory assist devices authorized for use 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
			Device Type
			Letter of Authorization
			Fact Sheets
			Other Documents
			Assigned Product Code04/13/2020
			Diaphragmatic Pacing Therapy System (DPTS)
			Synapse Biomedical, Inc. TransAeris Diaphragmatic Pacing Therapy System (DPTS)
			Healthcare Providers
				Patients
			IFU
				Surgical Procedures IFU
			QPR4/14/2020
			Diaphragmatic Pacing Therapy System (DPTS)
			Lungpacer Medical, Inc. Diaphragm Pacing Therapy System (DPTS)
			Healthcare Providers
				Patients
			Letter Granting EUA Amendment(s) (May 5, 2020)
				IFU
				Intermediate Cable IFU
				Live Catheter Kit IFU
				Handheld Controller IFU
			QPR04/22/2020
			Respiratory Assist Device
			ALung Technologies, Inc., Hemolung RAS
			Healthcare Providers
				Patients
			Instructions for Hemolung RAS
				Instructions for Hemolung CR4
			QLN05/01/2020
			Respiratory Muscle Stimulator
			Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device
			Healthcare Providers
				Patients
			IFU - Model A
				IFU - Model B
			QPR07/10/2020
			non-Invasive Vagus Nerve Stimulator
			electroCore, Inc., gammaCore Sapphire CV
			Healthcare Providers
				Patients
			IFU
			QPR06/30/2021
			Incentive Spirometer Accessory
			Tidal Medical Technologies LLC, InSee
			Healthcare Providers
				Patients
			Device User Manual
			QOO

                                                                                  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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