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.
Recommended Actions
- Determine if your face mask/covering is intended for medical purposes based on FDA’s criteria
- For medical purpose devices:
- Ensure compliance with labeling requirements
- Remove any unallowed claims (antimicrobial, antiviral, etc.)
- Document body-contacting materials
- For barrier face coverings:
- Conduct testing per ASTM F3502
- Document test results for filtration and airflow resistance
- Ensure compliance with design and material requirements
- For repurposed non-NIOSH FFRs:
- Implement proper segregation from NIOSH-approved devices
- Update labeling for source control use only
- Review and comply with CDC guidance for PPE use in healthcare settings
- Maintain records of compliance with guidance requirements
- 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
- FDA does not intend to object to distribution without 510(k), registration and listing, QSR, corrections and removals reporting, and UDI requirements
- Products must follow CDC guidance for PPE use during COVID-19
- Products are not substitutes for NIOSH-approved respirators or surgical masks
Relevant Guidances
- Design Considerations for Medical Devices Intended for Home Use
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms
- 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
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