May 12, 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 end of the PHE under section 319 of the PHS Act does not impact the FDA’s ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices remain in effect, and the FDA may continue to issue new EUAs going forward while the EUA declarations under section 564 of the Federal Food, Drug, and Cosmetic Act are in effect and when the criteria for issuance of an EUA are met. 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||CDRH-COVID19-DigitalHealthForPsychiatricDisorders@fda.hhs.gov|
|Gowns and other apparel||CDRH-COVID19-PPE@fda.hhs.gov|
|Masks, including surgical masks||CDRH-COVID19-SurgicalMasks@fda.hhs.gov|
|Ophthalmic devices for remote assessment and monitoring||CDRH-COVID19-Ophthalmic@fda.hhs.gov|
|Respirators, including N95 and KN95 respirators||CDRH-COVID19-SurgicalMasks@fda.hhs.gov|
|Sterilizers, disinfectant devices, and purifiers||CDRH-COVID19-SterilizersDisinfectantsPurifiers@fda.hhs.gov|
|Telethermographic systems, including infrared thermographic systems and thermal imaging cameras||CDRH-COVID19-Thermography@fda.hhs.gov|
|Thermometers, including infrared laser and temple devices||CDRH-COVID19-Thermometers@fda.hhs.gov|
|Ventilators and ventilator accessories||CDRH-COVID19-Ventilators@fda.hhs.gov|
|Viral transport media||COVID19Dx@fda.hhs.gov|
All General Questions
Contact the Division of Industry and Consumer Education (DICE).