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  7. Personal Protective Equipment EUAs
  1. COVID-19 Emergency Use Authorizations for Medical Devices

Personal Protective Equipment EUAs

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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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

Personal Protective Equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.

To help address concerns about availability during the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUAs) for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators. Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Guidance Documents (Medical Devices and Radiation-Emitting Products).

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an Interactive Review Template For Non-IVD Products.

Table of Personal Protective Equipment (PPE) EUAs

For information on EUAs that were previously issued but no longer in effect, including revoked EUAs, see Historical Information about Device Emergency Use Authorizations.

Umbrella EUA for Surgical Masks

On August 5, 2020, the FDA issued an umbrella EUA for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorized the emergency use of surgical masks that met certain performance requirements for use in healthcare settings by health care personnel (HCP) as PPE, to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. Surgical masks that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A as authorized surgical masks.

On March 6, 2023, the FDA revised and reissued the umbrella EUA for disposable, single-use surgical masks intended for use in health care settings by health care professionals during the COVID-19 pandemic. The revision authorizes emergency use of only those surgical masks listed in the EUA’s Appendix A as of the date of this reissuance. As a result of this revision, the FDA will no longer add surgical masks to Appendix A.

Appendix A: Authorized Surgical Masks

The table below includes a list of surgical masks authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.

All authorized surgical masks in the table below (Appendix A) are assigned the QMF product code.

Surgical Masks Removed from Appendix A

These surgical mask models had been on the list of authorized surgical masks in Appendix A but no longer meet the EUA's scope of authorization and thus are no longer authorized and have accordingly been removed from Appendix A.

N95 and Other Respirators EUAs

The table below includes information about respirators authorized for emergency use by healthcare personnel during the COVID-19 public health emergency.


Face Shields and Other Barrier EUAs

Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials. Availability of certain PPE are an integral part of routine patient care during the COVID-19 pandemic. The table below includes authorization information about the use of authorized face shields and other barriers for use during the COVID-19 public health emergency.

Withdrawal Due to Other Reasons

The personal protective equipment on this list have been withdrawn at the request of the EUA holder and thus are no longer authorized and have accordingly been removed from the list of authorized EUAs above.

If you have a question about: Send email to:
Masks, including surgical masks CDRH-COVID19-SurgicalMasks@fda.hhs.gov
Respirators, including N95 and KN95 respirators CDRH-COVID19-SurgicalMasks@fda.hhs.gov

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