The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) manufactured in China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19. These concerns are based on test results from the National Institute for Occupational Safety and Health (NIOSH) showing that some of these respirators do not meet their labeled performance standard.
This Letter to Health Care Providers describes:
- Changes to the FDA’s Emergency Use Authorization for respirators manufactured in China and removal of some of these respirators from the Appendix listing authorized respirators.
- Considerations for health care organizations when using or purchasing respirators.
- Actions the FDA has taken to help ensure the quality of respirators.
- Instructions for reporting problems with respirators to the FDA.