On May 26, 2020, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help address potential shortages of face masks, surgical masks, respirators, and face shields for use during the COVID-19 public health emergency:
- Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
These guidances help to address potential shortages by:
- Facilitating the safe reuse and conservation of surgical masks and respirators for medical purposes through the use of decontamination and bioburden reduction systems.
- Providing recommendations of alternatives and updated options for when FDA-cleared or NIOSH-approved N95 respirators are not available.
Both guidance documents are applicable for the duration of the public health emergency. The FDA continues to recommend face masks, surgical masks, respirators, and face shields be used according to their labeling, and federal, state and local requirements.