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.
What You Need to Know? 👇
What is the current FDA enforcement policy for face masks during COVID-19?
FDA maintains a flexible enforcement policy allowing distribution of face masks and barrier face coverings intended for medical purposes without full regulatory compliance, provided they don’t create undue risk and meet specific labeling requirements.
Are face masks considered medical devices under FDA regulations?
Face masks are medical devices when intended for medical purposes, such as use by healthcare personnel or disease prevention. Non-medical face masks for construction or industrial use don’t require FDA device authorization.
What’s the difference between face masks and barrier face coverings according to FDA?
Face masks cover nose and mouth for source control by general public and healthcare personnel. Barrier face coverings must meet ASTM F3502 standards for particulate filtration efficiency and provide measured degree of filtration.
Can non-NIOSH approved respirators be used as face masks under this policy?
Yes, existing stockpiles of non-NIOSH approved disposable filtering facepiece respirators can be distributed as face masks for source control only, provided they’re clearly segregated and labeled appropriately.
What labeling requirements must face masks meet under the enforcement policy?
Face masks must be accurately labeled, list body-contacting materials, recommend against surgical use or high-risk environments, and avoid claims about antimicrobial protection, infection prevention, or particulate filtration.
How long will this FDA enforcement policy remain in effect?
The policy remains effective for the duration of the HHS Secretary’s declaration under section 564 of the FD&C Act authorizing emergency use of devices, unless FDA revises or replaces the guidance.
What You Need to Do 👇
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