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

• Face masks: A mask, with or without a face shield, that covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels.  Face masks should be used by the general public and health care personnel as source control in accordance with CDC recommendations on Interim Infection Prevention and Control.
• Barrier face coverings: As described in ASTM F3502-21, a barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. 
• Surgical masks: A mask intended for medical purposes that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks are Class II medical devices. These masks meet certain fluid barrier protection standards and flammability requirements (that is, Class I or Class II, per 16 CFR 1610.4). Surgical masks are also tested for particulate and bacterial filtration efficiencies and biocompatibility and are considered personal protective equipment (PPE). While surgical masks may be effective in blocking splashes and large-particle droplets, they do not provide a reliable level of protection from aerosolized particles because of the loose fit between the surface of the mask and your face. Surgical masks are not respiratory protective devices, such as respirators.
• Respirators: Air purifying respirators, known as respirators, including filtering facepiece respirators (FFRs) such as N95s and surgical N95s, filter at least 95 percent of airborne particles. They are PPE that tightly fit the face and provide certain filtration efficiency levels to help reduce wearer exposure to pathogenic particles in a health care setting. They provide a higher level of protection against viruses and bacteria when properly fit-tested.

This CDC infographic (PDF - 227KB) explains the differences between surgical masks and N95 respirators.

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.

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 of masks.

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 Using PPE, How to Protect Yourself and Others, and When You’ve Been Fully Vaccinated.

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: 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.

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?"

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.

A: During the COVID-19 public health emergency, the CDC recommends healthcare personnel wear well-fitting source control at all times while they are in the healthcare facility, including in breakrooms or common areas where they might encounter co-workers or visitors.

When available, surgical masks (a specific type of face mask) are preferred over cloth face coverings for healthcare personnel as surgical masks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others.

• Non-surgical face masks, including cloth face coverings, should NOT be worn instead of a respirator or surgical mask if more than source control is needed.
• Wear an N95 or equivalent or higher-level respirator, instead of a face mask or barrier face covering, for:
  • Aerosol generating procedures (refer to "Which procedures are considered aerosol generating procedures in healthcare settings?" on the CDC's Clinical Questions about COVID-19: Questions and Answers page).
  • Surgical procedures that might pose a higher risk for transmission if the patient has COVID-19 (for example, that generate potentially infectious aerosols or involve anatomic regions where viral loads might be higher, such as the nose and throat, oropharynx, or respiratory tract). Refer to "During the COVID-19 pandemic, are there special considerations for surgical and other procedural care settings, including performance of aerosol-generating procedures (AGPs)?" on the CDC's Clinical Questions about COVID-19: Questions and Answers page.

Health care personnel should consult their institutional policies for further guidance on what type of face mask or respirator to use.

The CDC provides information on infection control measures for COVID-19 on its Clinical Questions about COVID-19: Questions and Answers page.

A: The FDA provides information on medical device shortages during the COVID-19 public health emergency and maintains a list of devices that it has determined to be either in shortage or permanently discontinued.

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 [email protected].

A: The FDA issued a Letter to Health Care Providers on Surgical Mask and Gown Conservation Strategies that describes these recommended strategies:

• Conventional capacity strategies
• Contingency capacity strategies
• Crisis or alternate strategies if surgical masks are running low or not available

The CDC provides additional information on Strategies for Optimizing the Supply of Facemasks, including surgical masks.

A: Face masks, barrier face coverings, and surgical masks are designed to serve as protective barriers and may still offer some protection even if they are used beyond the manufacturer's designated shelf life or expiration date. If there is no date available on the product label or packaging, facilities should contact the manufacturer. 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. For additional information please refer to the CDC's Strategies for Optimizing the Supply of Facemasks.

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.

A: The CDC does not recommend the reuse of disposable surgical masks that are intended to be used once. The FDA recognizes that there may be availability concerns with surgical masks during the COVID-19 public health emergency, but there are strategies to conserve surgical masks.

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

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

A: The CDC provides additional information on Strategies for Optimizing the Supply of N95 Respirators. As of May 2021, the CDC states that “the supply and availability of NIOSH-approved respirators have increased significantly over the last several months. Healthcare facilities should not be using crisis capacity strategies at this time and should promptly resume conventional practices.”  Reuse of FFRs is currently not recommended.

A: The FDA realizes that stakeholders such as healthcare 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 Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) 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. 

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.

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.

For details on the Emergency Use Authorizations for these devices, see:

• Personal Protective Equipment EUAs
• Face Mask EUA (PDF - 98KB)

If you need help with the EUA process for face masks, surgical masks, or respirators, contact [email protected].

To identify FDA-cleared surgical masks and respirators, search the 510(k) Premarket Notification database.

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.

If you need help with the pre-EUA process for face masks, surgical masks, or respirators, contact [email protected].

For additional information, refer to Emergency Use Authorization of Medical Products and Related Authorities.

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.

A: 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.

The Scope of Authorization includes performance metrics that must be met including liquid barrier performance, particulate filtration efficiency, air flow resistance, and use of biocompatible, non-cytotoxic, non-irritating, and non-sensitizing materials. Surgical masks that have been confirmed by the FDA to be within the Scope of Authorization are listed in Appendix A of the EUA as authorized surgical masks.

To be added to Appendix A, test reports must be submitted to the FDA demonstrating that the surgical mask meets the performance criteria.  Requests can be submitted to the FDA with the subject line "Surgical Masks EUA" to [email protected]. The Surgical Masks EUA Template for Addition to Appendix A (DOCX - 56KB) can be used to provide the required information.

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

The following surgical masks are not within the scope of this EUA:

• Surgical masks that are FDA-cleared
• Surgical masks that are manufactured in China
• Surgical masks that include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents

A: Respirators authorized by this EUA (PDF - 176KB) include:

1. Non-powered air-purifying particulate FFRs and reusable respirators such as elastomeric half and full facepiece respirators, approved by NIOSH in accordance with 42 CFR Part 84 and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection; and
2. Other powered air purifying respirators (PAPRs) approved by NIOSH, in accordance with 42 CFR Part 84, and that are listed on the NIOSH CEL for PAPRs with particulate protection

A: Unapproved devices or unapproved uses of FDA-approved or cleared devices must submit marketing applications under the traditional premarket pathways in order to continue marketing their products if the applicable emergency use authorization is revoked. 
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.

A: Face masks and barrier face coverings intended for a medical purpose, such as prevention of infectious disease transmission, are subject to FDA regulation. The FDA has issued guidance on regulatory flexibility for such products, as well as EUAs for face masks and surgical masks.

The guidance provides an enforcement discretion policy for face masks and barrier face coverings intended for a medical purpose for use during the COVID-19 public health emergency, such as for use as source control. 

Face masks, intended for use by health care personnel and the general public as source control to help stop the spread, may be authorized under the umbrella EUA for face masks (PDF - 92KB) without submitting documentation to the FDA if the face mask is within the Scope of the EUA. A face mask authorized under this EUA must comply with the Conditions of Authorization (Section IV) of the EUA.

For a surgical mask to be added to the Surgical Mask EUA Appendix A, test reports must be submitted to the FDA demonstrating that the surgical mask meets the performance criteria for liquid barrier protection. Requests can be submitted to the FDA with the subject line "Surgical Masks EUA" to [email protected]. The Surgical Masks EUA Template for Addition to Appendix A (PDF - 176KB) can be used to provide the required information.

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

The following surgical masks are not covered in the scope of this EUA:

• Surgical masks that are FDA-cleared
• Surgical masks that are manufactured in China
• Surgical masks that include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents.

A: Respirators require NIOSH approval. Once NIOSH approval is obtained, the respirator is authorized under the EUA for NIOSH-approved air-purifying respirators (PDF - 176KB). In some cases (for example, if the respirator claims to prevent specific diseases or infection, or if it includes antimicrobials or other additives), obtaining FDA clearance may be the appropriate pathway (see 21 CFR 878.4040).

Additional information is available in the Manufacturing and Distributing Respirators for Health Care Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic flowchart.

A: The Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency provides guidance on manufacturing or importing face masks, barrier face coverings, surgical masks, and respirators. Device Advice provides comprehensive regulatory assistance to manufacturers and importers. If you have additional questions, you may send an email to [email protected].

A: To help avoid shipment delays, review Importing COVID-19 Supplies and Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 for important information from the FDA on importing products, including face masks, barrier face coverings, surgical masks, and respirators to ensure that the proper documentation is submitted at the time of entry.

The FDA is ready and available to engage with importers to help minimize disruptions during the importing process. If you have any specific import questions related to COVID-19, you may email [email protected].

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.

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.

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

The FDA encourages health care facilities which anticipate a potential shortage or are experiencing an actual shortage to notify the FDA. For potential or actual supply issues, e-mail information to the FDA at [email protected].

For manufacturers:

Certain device manufacturers are now required under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to notify the FDA of an interruption or permanent discontinuance in manufacturing. Section 506J of the FD&C Act requires manufacturers to notify the FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States.

The FDA has issued a guidance to assist manufacturers in providing the FDA with timely and informative notifications about these changes in the production of certain medical device products. These notifications will help the FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency.

The FDA has prepared a list of medical device types and corresponding product codes identifying devices that the FDA believes are critical to the public health during the COVID-19 pandemic. This list is not exhaustive, and the FDA intends to update this list as the COVID-19 pandemic evolves.

Manufacturers of device types that are included on this list should review section 506J of the FD&C Act and FDA's guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, to determine whether they are required to notify the FDA.

Manufacturers should submit their notifications by email to [email protected] during the COVID-19 Public Health Emergency.  Please begin the email subject line with the word "Notification."

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

• In general, device manufacturers, importers, and device user facilities (health care facilities) must comply with the applicable medical device Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.
• Voluntary reports from health care personnel and users can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Health care personnel employed by organizations that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their organizations.