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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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), 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.
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:
|Digital health, particularly digital health devices for psychiatric disorders
|Gowns and other apparel
|Masks, including surgical masks
|Ophthalmic devices for remote assessment and monitoring
|Respirators, including N95 and KN95 respirators
|Sterilizers, disinfectant devices, and purifiers
|Telethermographic systems, including infrared thermographic systems and thermal imaging cameras
|Thermometers, including infrared laser and temple devices
|Ventilators and ventilator accessories
|Viral transport media
All General Questions
Contact the Division of Industry and Consumer Education (DICE).