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  5. FAQs on the Emergency Use Authorization for Face Masks (Non-Surgical)
  1. Emergency Situations (Medical Devices)

FAQs on the Emergency Use Authorization for Face Masks (Non-Surgical)

Q: Why did the FDA re-issue the Emergency Use Authorization (EUA) for face masks?

A: The FDA received questions about the original face mask EUA posted on April 18, 2020. On April 24, 2020, the FDA updated and re-issued the EUA to clarify that face masks, including cloth face coverings, that are authorized by the EUA are only authorized for use by the general public and health care personnel as source control.

These face masks are not authorized to be personal protective equipment, meaning they are not a substitute for filtering face piece respirators or for surgical face masks.

Q: What does wearing a face mask for source control mean?

A: Source control means preventing the transmission of infection through a person’s respiratory secretions which are produced when speaking, coughing, or sneezing. Face masks, including cloth face coverings, help with source control by covering the wearer’s mouth and nose. COVID-19 may be spread through respiratory secretions by individuals who may or may not have symptoms of COVID-19.

For more information on source control, see the CDC’s Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings.

Cloth face coverings made from common, easily accessible materials are an additional, voluntary public health approach to help slow the spread of COVID-19. The CDC has a list of FAQs about Cloth Face Coverings for use by the general public. 

Q: During the COVID-19 public health emergency, when should health care personnel wear face masks?

A: Face masks are not personal protective equipment. Health care facilities should not purchase or offer these masks as substitutes for surgical masks or filtering facepiece respirators. Face masks, including cloth facial coverings, when used as source control, may help in preventing or slowing the spread of COVID-19. Face masks are authorized under this EUA to be worn for source control only, including in the healthcare setting.

Personal protective equipment (i.e., surgical masks and filtering facepiece respirators) are critical supplies that must continue to be reserved for health care personnel and other medical first responders, as recommended in the CDC’s Strategies for Optimizing the Supply of Facemasks.

Face masks should NOT be used in place of surgical masks or filtering facepiece respirators to provide protections such as:

  • Liquid barrier protection
  • Antimicrobial or antiviral protection, prevention, or reduction
  • Respiratory protection
  • Particulate filtration
  • Protection in high-risk aerosol generating procedures

Q: What type of face mask should someone who is suspected or confirmed with COVID-19 wear?

A: In What to Do if You Are Sick, the CDC recommends wearing a cloth face covering to control the spread of the virus to others. The CDC also provides recommendations to prevent transmission from infected individuals.

Q: How should health care facilities prioritize the use of masks?

A: The CDC provides strategies for optimizing the supply of face masks when there is limited supply. The FDA also provides information about conservation strategies for face masks (Archived).

 
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