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  1. Coronavirus (COVID-19) and Medical Devices

Contacts for Medical Devices Related to COVID-19

August 11, 2026 - 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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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. 

On June 29, 2026, the HHS Secretary determined that circumstances no longer exist justifying the authorization of emergency use of (1) in vitro diagnostics for detection and/or diagnosis of the SARS-CoV-2 virus; (2) personal respiratory protective devices; and (3) medical devices, including alternative products used as medical devices. On the basis of this determination, the HHS declarations authorizing emergency use of these medical devices for COVID-19 will be terminated, effective December 26, 2026. On the effective date of this termination, the COVID-19 emergency use authorizations (EUA) for devices currently listed on this website will no longer be in effect.  

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 testsCOVID19DX@fda.hhs.gov
EUAs for other devices, including PPE, respirators, ventilatorsCDRH-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 TestsCOVID19DX@fda.hhs.gov
Digital health, particularly digital health devices for psychiatric disordersCDRH-COVID19-DigitalHealthForPsychiatricDisorders@fda.hhs.gov
GlovesCDRH-COVID19-PPE@fda.hhs.gov
Gowns and other apparelCDRH-COVID19-PPE@fda.hhs.gov
Infusion pumpsCDRH-COVID19-InfusionPumps@fda.hhs.gov
Masks, including surgical masksCDRH-COVID19-SurgicalMasks@fda.hhs.gov
Ophthalmic devices for remote assessment and monitoringCDRH-COVID19-Ophthalmic@fda.hhs.gov
Respirators, including N95 and KN95 respiratorsCDRH-COVID19-SurgicalMasks@fda.hhs.gov
Sterilizers, disinfectant devices, and purifiersCDRH-COVID19-SterilizersDisinfectantsPurifiers@fda.hhs.gov
Telethermographic systems, including infrared thermographic systems and thermal imaging camerasCDRH-COVID19-Thermography@fda.hhs.gov
Thermometers, including infrared laser and temple devicesCDRH-COVID19-Thermometers@fda.hhs.gov
Ventilators and ventilator accessoriesCDRH-COVID19-Ventilators@fda.hhs.gov
Viral transport mediaCOVID19Dx@fda.hhs.gov

Other Questions

If you have a question about:Send email to:
Importing PPE, including N95 and KN95 respiratorsCOVID19FDAIMPORTINQUIRIES@fda.hhs.gov
Fraudulent products, such as COVID-19 test kits and at-home test kitsFDA-COVID-19-Fraudulent-Products@fda.hhs.gov

All General Questions

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

 

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