NIOSH is requesting feedback about the possibility of incorporating elements of the Food and Drug Administration’s (FDA’s) clearance process for respiratory protective devices (RPDs) into NIOSH's own approval process for RPDs used in healthcare. According to the March 14 Federal Register notice, an internal NIOSH survey report shows that NIOSH-approved RPDs that are not FDA-cleared medical devices are also being used to protect healthcare workers from inhalation hazards.
NIOSH hopes to determine whether there are gaps in the current approval process and enhance harmonization of the FDA clearance and NIOSH approval processes for surgical N95s. The agency also requests data on the effectiveness of current NIOSH particulate filtration testing.
Comments must be received by April 14. To learn more or submit comments, visit the NIOSH website.