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  6. Contacts for Medical Devices Related to COVID-19
  1. Coronavirus (COVID-19) and Medical Devices

Contacts for Medical Devices Related to COVID-19

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.

If you have a question about: Send email to:
EUAs for in vitro diagnostic tests [email protected]
EUAs for other devices, including PPE, respirators, ventilators [email protected]

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 [email protected]
Digital health, particularly digital health devices for psychiatric disorders [email protected]
Gloves [email protected]
Gowns and other apparel [email protected]
Infusion pumps [email protected]
Masks, including surgical masks [email protected]
Ophthalmic devices for remote assessment and monitoring [email protected]
Respirators, including N95 and KN95 respirators [email protected]
Sterilizers, disinfectant devices, and purifiers [email protected]
Telethermographic systems, including infrared thermographic systems and thermal imaging cameras [email protected]
Thermometers, including infrared laser and temple devices [email protected]
Ventilators and ventilator accessories [email protected]
Viral transport media [email protected]

Other Questions

If you have a question about: Send email to:
Importing PPE, including N95 and KN95 respirators [email protected]
Fraudulent products, such as COVID-19 test kits and at-home test kits [email protected]

All General Questions

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

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