Letter Permitting Medical Use of all NIOSH Approved N95
U.S. Food & Drug Administration. (2020). Letter Permitting Medical Use of all NIOSH Approved N95.
This letter from the U.S. Food & Drug Administration authorizes emergency use of (1) all disposable filtering facepiece respirators (FFR) approved by the National Institute for Occupational Safety and Health (NIOSH) in accordance with 42 CFR Part 84, as non-powered air-purifying particulate FFRs, and (2) FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, for use in healthcare settings by healthcare personnel (HCP)2 to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the Coronavirus Disease 2019 (COVID-19).