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 In this section:

        Emergency Situations (Medical Devices)

Coronavirus (COVID-19) and Medical Devices

                        
                At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19 Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)
          Coronavirus (COVID-19) and Medical DevicesEmergency Situations (Medical Devices) Coronavirus (COVID-19) and Medical Devices
  	
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    PrintNovember 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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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?


On this page:

Info on specific devices

	COVID-19 Tests
		Personal Protective Equipment (PPE)
		Other Medical Devices and Topics
		Archived Information on Medical Devices and Topics Relating to COVID-19

COVID-19 Tests Granted Traditional Marketing Authorization by the FDA

We remain committed to expanding access to safe and effective tests through the FDA's traditional premarket review pathway.

Emergency Use Authorizations (EUAs) for Medical Devices During COVID-19

EUAs for tests, personal protective equipment (PPE), and more.

Contacts for Medical Devices During COVID-19

Contacts for EUAs, device availability, and more.

COVID-19 Tests

For general information:

COVID-19 Test Basics
	**At-Home COVID-19 Tests**
	At-Home OTC COVID-19 Diagnostic Tests
		Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
		At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
		Counterfeit At-Home OTC COVID-19 Diagnostic Tests
	Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
	Medical Device Safety, including Safety Communications and Letters to Health Care Providers about COVID-19 testsFor test developers:

FAQs on Testing for SARS-CoV-2
	FAQs on Viral Transport Media during COVID-19For health care providers and clinical laboratory staff:

SARS-CoV-2 Viral Mutations: Impact on COVID-19 TestsGuidances:

Policy for Coronavirus Disease-2019 Tests (Revised)
	Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised)Masks and Respirators

For general information:

Face Masks, Including Surgical Masks, and Respirators for COVID-19Flowcharts:

Considerations for Selecting Respirators for Your Health Care FacilityInformation on respirators and respirator EUAs

N95 and Other Respirators EUAsGuidance:

Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health EmergencyPersonal Protective Equipment (PPE)

Personal Protective Equipment EUAsVentilators and Ventilator Accessories

Ventilators and Ventilator Accessories EUAsOther Medical Devices and Topics

Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents
	Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA's Response
	Information for Filing Personal Protective Equipment and Medical Devices During COVID-19
	Registration and Listing of Medical Devices Relating to the COVID-19 PandemicArchived Information on Medical Devices and Topics Relating to COVID-19
	Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel
	Center for Devices and Radiological Health's Response to Coronavirus (COVID-19): Infographic
	Considerations for Selecting Respirators for Your Health Care Facility
	COVID-19 Tests and Collection Kits Authorized by the FDA: Infographic
	Digital Health Policies and Public Health Solutions for COVID-19
	FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
	FAQs on Home-use Blood Glucose Meters Utilized Within Hospitals During the COVID-19 Pandemic
	FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data
	Hospital Beds, Stretchers, and Mattresses During the COVID-19 Pandemic
	Non-contact Temperature Assessment Devices During the COVID-19 Pandemic
	Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel
	Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19
	SARS-CoV-2 Reference Panel Comparative Data
	Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
	South Korea's Response to COVID-19
	Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras) | FDA
	UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus

                                                                                  Content current as of:
      11/08/2023
                  
                   
Regulated Product(s)
		 Medical DevicesHealth Topic(s)
			  CoronavirusCoronavirus (COVID-19) and Medical Devices                
                          

                        At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19
 
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