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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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


Remote or wearable patient monitoring devices include (1) non-invasive remote monitoring devices that measure or detect common physiological parameters and, (2) non-invasive monitoring devices that wirelessly transmit patient information to their health care provider or other monitoring entity. The FDA has issued EUAs for certain remote or wearable patient monitoring devices to help increase the availability of monitoring and treatment of patients and to help address reduction of healthcare provider exposure to SARS-CoV-2 during the COVID-19 pandemic.

The table below lists the remote or wearable patient monitoring 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 Code04/21/2020
			Remote Patient Monitor
			IntelliVue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH
			Healthcare Providers
				Patients
			Instructions for IntelliVue Active Display
				Instructions for IntelliVue Patient Monitors
			QLJ04/26/2020
			Remote Patient Monitor
			VitalConnect, Inc., VitalPatch
			Healthcare Providers
				Patients
			Instructions for Use, VitalPatch Biosensor
			QNY05/05/2020
			Remote Patient QT Interval Monitor
			PhysiolGuard, ECG-QT Analysis System
			Healthcare Providers
				Patients
			Lay User Instructions for Use
				MiCorA100 User Manual
				Analysis Platform User Manual
			QNY05/08/2020
			Patient Isolation Transport Unit (PITU)
			Patient Isolation Transport Unit (PITU) Device
			Healthcare Providers
				Patients
			
			QLE05/11/2020
			Nurse Call System
			Ascom(US), Inc., teleCARE
			Healthcare Providers
				Patients
			
			QNZ05/14/2020
			Remote Patient QT Interval Monitor
			G Medical Innovations, Ltd., VSMS Patch
			Healthcare Providers
				Patients
			Professional User Guide, VSMS Patch
				Quick Start Guide, VSMS Patch
			QNY

FDA Guidances

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

                                                                                  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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