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 In this section:

                Coronavirus (COVID-19) and Medical Devices

Coronavirus (COVID-19) and Medical Devices

                        At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19 Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)
          Coronavirus (COVID-19) and Medical Devices
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19Coronavirus (COVID-19) and Medical Devices Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
  
  	
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    Print**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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency* (see List 1) are no longer in effect.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:

The basics on face masks, barrier face coverings, surgical masks, and respirators
	Using face masks, barrier face coverings, surgical masks, and respirators
	Emergency Use Authorizations for face masks, surgical masks, and respirators
	Purchasing face masks, barrier face coverings, surgical masks, and respirators
	Notifying the FDA of shortages of or problems with face masks, surgical masks, or respiratorsThe Basics on Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators

Q: Is there a difference between a face mask, a barrier face covering, a surgical mask, and a respirator?
	**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, or in other situations as appropriate based on personal circumstances.
	**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.   
Q: Which face masks, barrier face coverings, and surgical masks are medical devices regulated by the FDA?
	**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.

Using Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators

Q: Do face masks and barrier face coverings provide protection from coronavirus?
	**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.   
Q: Are face masks, barrier face coverings, surgical masks, and respirators safe to wear?
	**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.

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.   
Q: What does wearing a face mask or a barrier face covering for 'source control' mean?
	**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.   
Q: When should health care personnel wear face masks, barrier face coverings, or respirators?
	**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).

Q: How can health care facilities know if there may be a shortage so they can prepare?
	**A:** The FDA provides information on the Medical Device Shortages List web page.

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.   
Q: How do I know what the manufacturer-designated shelf life is?
	**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.   
Q: Can face masks and barrier face coverings be cleaned and reused during COVID-19?
	**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.

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.   
Q: Can I still use non-NIOSH-approved FFRs that are no longer authorized by FDA?
	**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.

Emergency Use Authorizations for Face Masks, Surgical Masks, and Respirators

Q: Why does the FDA issue Emergency Use Authorizations (EUAs)?
	**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
	Other Medical Device EUAs
	Face Mask EUA (PDF - 98KB)If you need help with the EUA process for face masks, surgical masks, or respirators, contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.

To identify FDA-cleared surgical masks and respirators, search the 510(k) Premarket Notification database.   
Q: What is a pre-EUA?
	**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 CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.

For additional information, refer to Emergency Use Authorization of Medical Products and Related Authorities.   
Q: What is an Umbrella EUA?
	**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.   
Q: What type of mask is authorized under the umbrella EUA for surgical 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.

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.

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.

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   
Q. Since the FDA has removed the surgical mask and surgical respirator product codes from the device shortage list, will the related emergency use authorizations (EUAs) and enforcement policies be revoked?
	**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.   
Q. What types of respirators are authorized under the umbrella EUA for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency?
	**A:** Respirators authorized by this EUA (PDF - 176KB) include:

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
	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   
Q. If I am producing surgical masks or respirators under an EUA during COVID-19, what do I need to do to continue marketing my product after the emergency is over?
	**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.

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.

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.

Purchasing Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators

Q: I would like to purchase face masks, barrier face coverings, surgical masks, or respirators for health care personnel. Where can I find ones that can be used in health care?
	**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:

To identify FDA-cleared products, search the 510(k) Premarket Notification database using device name (such as, surgical mask) or product code (such as FXX, OUK, or OXZ).
	To find NIOSH-approved surgical N95s (since 2018, NIOSH has approved certain surgical N95s, per FDA/CDC MOU 225-18-006), search the NIOSH certified equipment list (CEL).
	To find a list of emergency use authorized products for masks, respirators, and other personal protective equipment (PPE), search the personal protective equipment EUAs.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.   
Q: How can I tell if the face masks, barrier face coverings, surgical masks, or respirators I want to purchase are counterfeit or fraudulent?
	**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.

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.

Notifying the FDA of Shortages of or Reporting Problems with Face Masks, Barrier Face Coverings, Surgical Masks, or Respirators

Q: How do I notify the FDA of a shortage of face masks, surgical masks, or respirators?
	A: Contact the FDA about a medical device supply chain issue.   
Q: How do I report to the FDA about a problem with face masks, barrier face coverings, surgical masks, or respirators?
	**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.

                                                                                  Content current as of:
      11/08/2023
              
              
Regulated Product(s)
		 Medical DevicesHealth Topic(s)
			  CoronavirusCoronavirus (COVID-19) and Medical Devices

          
                        At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19
 
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