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  1. Emergency Situations (Medical Devices)

Coronavirus (COVID-19) and Medical Devices

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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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

On this page:

COVID-19 Tests Granted Traditional Marketing Authorization by the FDA

We remain committed to expanding access to safe and effective tests through the FDA's traditional premarket review pathway. 

Emergency Use Authorizations (EUAs) for Medical Devices During COVID-19

EUAs for tests, personal protective equipment (PPE), and more.

COVID-19 Tests

For general information:

For test developers:

For health care providers and clinical laboratory staff:

Guidances:

Masks and Respirators

For general information:

Flowcharts:

Information on respirators and respirator EUAs

Guidance:

Personal Protective Equipment (PPE)

Ventilators and Ventilator Accessories

Other Medical Devices and Topics



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