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 In this section:

                Coronavirus (COVID-19) and 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 Devices
          Contacts for Medical Devices Related to COVID-19Coronavirus (COVID-19) and Medical Devices Contacts for Medical Devices Related to COVID-19
  
  	
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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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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)*, 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?


Questions about Emergency Use Authorizations (EUAs)

The FDA has issued EUAs for specific devices for use to diagnose, treat, or prevent COVID-19. The FDA has specific email addresses for questions on, or for submitting, these EUAs.

If you have a question about:
			Send email to:EUAs for in vitro diagnostic tests
			COVID19DX@fda.hhs.govEUAs for other devices, including PPE, respirators, ventilators
			CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov

Enforcement Policy Questions

The FDA has issued enforcement policies for certain devices. Each enforcement policy lists an FDA email address for questions.

If you have a question about the policy on:
			Send email to:COVID-19 Tests
			COVID19DX@fda.hhs.govDigital health, particularly digital health devices for psychiatric disorders
			CDRH-COVID19-DigitalHealthForPsychiatricDisorders@fda.hhs.govGloves
			CDRH-COVID19-PPE@fda.hhs.govGowns and other apparel
			CDRH-COVID19-PPE@fda.hhs.govInfusion pumps
			CDRH-COVID19-InfusionPumps@fda.hhs.govMasks, including surgical masks
			CDRH-COVID19-SurgicalMasks@fda.hhs.govOphthalmic devices for remote assessment and monitoring
			CDRH-COVID19-Ophthalmic@fda.hhs.govRespirators, including N95 and KN95 respirators
			CDRH-COVID19-SurgicalMasks@fda.hhs.govSterilizers, disinfectant devices, and purifiers
			CDRH-COVID19-SterilizersDisinfectantsPurifiers@fda.hhs.govTelethermographic systems, including infrared thermographic systems and thermal imaging cameras
			CDRH-COVID19-Thermography@fda.hhs.govThermometers, including infrared laser and temple devices
			CDRH-COVID19-Thermometers@fda.hhs.govVentilators and ventilator accessories
			CDRH-COVID19-Ventilators@fda.hhs.govViral transport media
			COVID19Dx@fda.hhs.gov

Other Questions

If you have a question about:
			Send email to:Importing PPE, including N95 and KN95 respirators
			COVID19FDAIMPORTINQUIRIES@fda.hhs.govFraudulent products, such as COVID-19 test kits and at-home test kits
			FDA-COVID-19-Fraudulent-Products@fda.hhs.gov

All General Questions

Contact the Division of Industry and Consumer Education (DICE).

                                                                                  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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