Workshop Proceedings Addresses NIOSH, FDA Processes for Evaluating N95s in Healthcare

Published February 15, 2017

​The proceedings of an August 2016 workshop on the integration of two federal agencies’ processes to certify and approve N95 respirators for healthcare settings is now available from the National Academies of Sciences, Engineering, and Medicine. Both NIOSH and the Food and Drug Administration (FDA) have responsibilities to evaluate and regulate respiratory protective devices (RPDs) for healthcare workers. As described in the proceedings, the distinction between NIOSH approval and FDA clearance creates confusion among healthcare professionals and others, and the agencies are examining ways to streamline the approach for regulatory oversight and approvals for N95 respirators used in healthcare.

Participants in the workshop discussed the strengths and limitations of current test methods for N95 respirators and next steps in research for improving test methods. Other discussions focused on priorities for research and standards development for filtration performance and fluid resistance, and for flammability and biocompatibility/usability.

A PDF of the workshop proceedings can be downloaded from the National Academies website.

Related: An internal NIOSH survey report published in January 2014 showed that NIOSH-approved RPDs that are not FDA-cleared medical devices were also being used to protect healthcare workers from inhalation hazards. Two months later, NIOSH requested feedback about the possibility of incorporating elements of FDA’s clearance process for RPDs into NIOSH's own approval process for RPDs used in healthcare. Information and materials related to the associated public comment period are available on NIOSH’s website.