The Food and Drug Administration (FDA) recently issued two letters that allow for greater flexibility in the use of filtering facepiece respirators (FFRs). The recommendations were made based on the evolving COVID-19 public health emergency and FFR shortages.
On March 24, the FDA concluded that based on available scientific evidence certain imported disposable FFRs that are not approved by the National Institute for Occupational Safety and Health (NIOSH) are appropriate to protect public health or safety. The administration issued a letter authorizing the use of imported, non-NIOSH approved FFRs.
This is a continued effort by the FDA to increase the availability of FFRs. Previously on March 2, the FDA issued a letter authorizing the emergency use of, (1) all disposable FFRs approved by NIOSH, and (2) FFRs that were NIOSH-approved but have since passed the manufacturers' recommended shelf-life for use in health care settings by health care personnel. The letter was issued to help prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 pandemic.
In addition to the above letters, NIOSH has also provided two appendixes (Appendix A and Appendix B) detailing manufacturers and model numbers of approved FFRs that are now authorized for use by HCPs. These listing includes several models that are of the P95, R95, N99, N100 and P100 filtration classes.