The reuse of barrier face coverings should be determined based upon the manufacturer's instructions, which may include washing and subsequent wear.

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A: The CDC recommends reusable face masks be washed after each use and provides information on the washing of cloth face masks.

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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.

A: The FDA regulates face masks, including cloth face coverings, barrier face coverings, and surgical masks as medical devices when they are intended for a medical purpose. Medical purposes include uses related to helping prevent the spread of COVID-19. Face masks intended for use by the general public for non-medical purposes, such as for use in construction and other industrial applications, are not medical devices.

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?

To identify FDA-cleared products, search the 510(k) Premarket Notification database. The FDA has also issued Personal Protective Equipment EUAs and Other Medical Device EUAs.

A: The FDA does not maintain a list of face mask, barrier face covering, surgical mask, or respirator suppliers. If you are a health care facility, check with your supplier, distributor, or your local health department. However, be aware resources are available:

Manufacturers, importers, and distributors must also comply with the conditions of authorization found in Section IV of the EUA Letter of Authorization (PDF - 101KB).

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A: The removal of a product code from the device shortages list does not impact the existing Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Umbrella EUA for surgical masks, or EUA for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency. The policy and EUAs remain in effect at this time.

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Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may authorize the emergency use of an unapproved or uncleared medical product or an unapproved / uncleared use of an approved/cleared medical product for certain emergency circumstances after the HHS Secretary has made a declaration of emergency or threat justifying emergency use. The FDA Commissioner may issue an EUA to authorize a medical product for use in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, or available alternatives when certain criteria for issuance are met. The Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices that the FDA has issued related to COVID-19 may be revised, terminated, or revoked as appropriate.

A: EUAs authorize the emergency use of unapproved medical devices. The EUA authority allows the FDA to help strengthen the nation's public health protections against emerging infectious disease threats by facilitating the availability and use of medical devices needed during public health emergencies.

You may also want to check with the Association for Health Care Resource & Materials Management (AHRMM) of the American Hospital Association, which maintains the AHRMM Novel Coronavirus (COVID-19) Update on health care supply chain issues and includes vetted non-traditional supplies, companies offering supplies at no cost, and alternate supply channels.

The user should inspect all masks prior to use and, if there are concerns such as degraded materials (such as elastic) or visible tears, the product should be discarded.

A: The CDC provides information on infection control measures for COVID-19, including: Clinical Questions about COVID-19: Questions and Answers, Types of Masks and Respirators, and Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Barrier face coverings and face masks, including cloth face coverings, intended for a medical purpose, such as prevention of infectious disease transmission, are subject to FDA regulation. The FDA has issued a policy of regulatory flexibility for such products, as well as an emergency use authorization (EUA) for face masks. For more information, see "I'm interested in manufacturing face masks or surgical masks for the COVID-19 pandemic. What do I need to do?"

A: Manufacturers must submit marketing applications under the traditional premarket pathways in order to continue marketing their products if the applicable emergency use authorization is revoked.

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A: Many EUAs apply only to a specific medical device. Generally, an umbrella EUA authorizes many devices that meet specific criteria for that device type, helping to facilitate access to those devices by streamlining the process associated with EUAs (for example, EUA request submission and FDA authorization) for any medical devices that meet the requirements within the EUA.

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A: Source control refers to a person's use of barrier face coverings or face masks, including cloth face coverings, to cover the person's mouth and nose when they are talking, sneezing, or coughing to reduce the likelihood of transmission of infection by preventing the spread of respiratory secretions and large particles. COVID-19 may be spread by individuals who may or may not have symptoms of COVID-19. The general public's use of cloth face coverings made from common, easily accessible materials, are an additional public health approach to help slow the spread of COVID-19. The CDC has information on Types of Masks and Respirators for the general public.

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A: Face masks and barrier face coverings should generally be used for source control, meaning they may help prevent people who have COVID-19 from spreading the virus to others. These products may also help limit exposure to respiratory droplets and large particles but are not a substitute for filtering facepiece respirators or surgical masks. Please refer to CDC's webpage for recommendations regarding use and care of masks.

A: On August 5, 2020, the FDA issued an umbrella EUA in response to insufficient availability of disposable, single-use surgical masks. Surgical masks within the Scope of Authorization of this EUA are authorized for emergency use in health care settings by health care personnel as PPE.

For more information on source control, see the CDC's Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic.

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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.

A: The FDA realizes that stakeholders such as health care facilities and states may continue to have a supply of non-NIOSH-approved FFRs that were authorized prior to FDA's July 6, 2021 revocation of both EUAs concerning non-NIOSH-approved FFRs. The Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency explains that the FDA generally does not intend to object, for the duration of the public health emergency, to the further distribution and use of existing stockpiles of non-NIOSH-approved disposable FFRs for use as face masks for source control by the general public and HCP without compliance with certain regulatory requirements, where such use does not create an undue risk in light of the public health emergency. More information is included in the guidance.

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A: To help prepare for potential and current emergencies, the FDA works with medical device developers to prepare pre-EUA packages when appropriate. A pre-EUA package contains data and information about the safety, quality, and effectiveness of the product, its intended use, and information about the emergency or potential emergency. The pre-EUA process allows the FDA's scientific and technical subject matter experts to begin a review of information and consideration of the EUA statutory criteria, assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA, and also helps to facilitate completion of EUA requests during a current emergency declaration.

All authorized surgical masks listed in Appendix A were listed in Appendix A at the time of reissuance and meet the following performance metrics: liquid barrier performance, flammability performance, particulate filtration efficiency, air flow resistance, and use of biocompatible, non-cytotoxic, non-irritating, and non-sensitizing materials.

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A: The FDA encourages reporting of any adverse events or suspected adverse events experienced with face masks, barrier face coverings, surgical masks, or respirators.

A: If worn properly, face masks, barrier face coverings, surgical masks, or respirators may reduce the chance of spreading a COVID-19 infection between you and those around you. The CDC provides information on How to Protect Yourself and Others, and Staying Up to Date with Your COVID-19 Vaccines.

If you need help with the pre-EUA process for face masks, surgical masks, or respirators, contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.

FDA-cleared surgical masks and respirators have been used by health care personnel for years and have been worn in health care facilities during extended procedures without harm to the wearer. Health care personnel with medical conditions should discuss concerns they may have with wearing respirators with their own health care providers. Health care personnel should follow the manufacturer's instructions and their facility's policies for use of all PPE.

A: The FDA does not have a list of all counterfeit or fraudulent products. To report fraudulent COVID-19 products to the FDA, email FDA-COVID-19-Fraudulent-Products@fda.hhs.gov. The CDC provides information on identifying counterfeit respirators at Counterfeit Respirators / Misrepresentation of NIOSH-Approval.

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The FDA is interested in hearing from health care facilities and other stakeholders about shortages and potential shortages they may be experiencing. You may email the FDA at deviceshortages@fda.hhs.gov.

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The FDA issued two draft guidances: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency as well as Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Although these draft guidances are not for implementation at this time, manufacturers are encouraged to pursue any required marketing submissions through the appropriate regulatory pathway (for example, 510(k), De Novo, PMA) during the public health emergency if they plan to continue distribution after the public health emergency ends or the relevant EUA declaration is terminated.

A: Face masks, barrier face coverings, surgical masks, and respirators all cover a wearer's nose and mouth, but they differ in several aspects.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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A: The manufacturer-designated shelf life or expiration date may be found on the product labeling or packaging, or you can contact the manufacturer directly.

If you need help with the EUA process for face masks, surgical masks, or respirators, contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.

Device manufacturers are encouraged to pursue marketing applications through the appropriate regulatory pathway (such as 510(k), De Novo request, or PMA) during the emergency so that devices can remain on the market once the EUA is no longer in effect. For more information, see FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic.