September 16, 2021:
Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
Guidance for Industry and Food and Drug Administration Staff
FDA Issues Revised Policy on Face Masks and Respirators During COVID-19
The FDA issued a revised guidance: Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) to help expand the availability of face masks, barrier face coverings, and face shields for the general public, including health care personnel, and surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency.
Facts about the guidance
The FDA revised this guidance to:
- Include barrier face coverings intended for a medical purpose but not intended to provide liquid barrier protection within the scope of this guidance.
- Provide recommendations about submicron particulate filtration efficiency, airflow resistance, and leakage assessments for barrier face coverings as described in ASTM F3502-21: Standard Specification for Barrier Face Coverings.
- Remove reference to alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available based on current recommendations that healthcare facilities should not be using crisis capacity strategies at the time of issuance of this guidance.
- Add a policy that, during the public health emergency, the FDA generally does not intend to object to stockpiled, non-NIOSH-approved respirators being further distributed and used as face masks for source control (as opposed to being used as FFRs for respiratory protection) where such use does not create an undue risk in light of the public health emergency. More information is included in the guidance.
If you have questions about this guidance, contact the Division of Industry and Consumer Education.