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Face Masks and Barrier Face Coverings for Medical Purposes During the COVID-19 Public Health Emergency

This guidance covers face masks and barrier face coverings intended for medical purposes during the COVID-19 public health emergency. It specifically addresses: - Face masks for source control use by healthcare personnel and general public - Barrier face coverings providing source control and particulate filtration - Face masks not intended for medical purposes - Stockpiled non-NIOSH-approved disposable filtering facepiece respirators used as face masks The guidance does not apply to anesthetic masks, oxygen masks, ventilator masks, or resuscitator masks.

  1. Determine if your face mask/covering is intended for medical purposes based on FDA’s criteria
  2. For medical purpose devices:
    • Ensure compliance with labeling requirements
    • Remove any unallowed claims (antimicrobial, antiviral, etc.)
    • Document body-contacting materials
  3. For barrier face coverings:
    • Conduct testing per ASTM F3502
    • Document test results for filtration and airflow resistance
    • Ensure compliance with design and material requirements
  4. For repurposed non-NIOSH FFRs:
    • Implement proper segregation from NIOSH-approved devices
    • Update labeling for source control use only
  5. Review and comply with CDC guidance for PPE use in healthcare settings
  6. Maintain records of compliance with guidance requirements
  7. Monitor FDA communications for updates to the policy

Key Considerations

Non-clinical testing

  • For barrier face coverings: Must be evaluated for submicron particulate filtration efficiency and airflow resistance according to ASTM F3502
  • For barrier face coverings: Must meet design, leakage assessment, material, and flammability criteria per ASTM F3502

Labelling

  • Must accurately describe product as face mask or barrier face covering (not as surgical mask or respirator)
  • Must include list of body-contacting materials
  • Must include recommendations against use in surgical settings, high infection risk settings, or near high heat/flammable gas
  • Must not claim antimicrobial/antiviral protection or infection prevention
  • For repurposed non-NIOSH FFRs: Must be clearly identified as face masks for source control only

Biocompatibility

  • Must not include drugs, biologics, or nanoparticles

Safety

  • Must not create undue risk in intended use
  • Must be segregated from NIOSH-approved FFRs when repurposed as face masks

Other considerations

  • ASTM F3502: Standard Specification for Barrier Face Coverings

Original guidance

  • Face Masks and Barrier Face Coverings for Medical Purposes During the COVID-19 Public Health Emergency
  • HTML / PDF
  • Issue date: 2023-09-05
  • Last changed date: 2023-09-05
  • Status: FINAL
  • Official FDA topics: Medical Devices, Labeling, Premarket, Coronavirus
  • ReguVirta summary file ID: 2bd8dcb4007b8d14ac73581e928a286f
This post is licensed under CC BY 4.0 by the author.