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  1. Emergency Situations (Medical Devices)

Coronavirus (COVID-19) and Medical Devices

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?

March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:

  • Developing a transition implementation plan,
  • Submitting a marketing submission, and
  • Taking other actions with respect to these devices.

The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

Additional Resources:

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

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

Contacts for Medical Devices During COVID-19

Contacts for EUAs, device availability, enforcement policies, and more.

COVID-19 Tests

For general information:

For test developers:

For health care providers and clinical laboratory staff:


Masks and Respirators

For general information:


Information on respirators and respirator EUAs


Personal Protective Equipment (PPE)


Ventilators and Ventilator Accessories

For general information:

For health care professionals:


Other Medical Devices and Topics


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