Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop


Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the National Academies. Learn more about the differences between Reports and Proceedings.

The Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating respiratory protective devices (RPDs) for health care workers. To provide input to NIOSH and FDA and to discuss potential next steps to integrate the two agencies’ processes to certify and approve N95 respirators for use in health care settings, a workshop was held by the National Academies of Sciences, Engineering, and Medicine (the National Academies). The workshop was focused on exploring the strengths and limitations of several current test methods for N95 respirators as well as identifying ongoing research and research needs. The workshop resulted from discussions between FDA and NIOSH and from discussions of the National Academies’ Standing Committee on Personal Protective Equipment for Workplace Safety and Health. This workshop provided the opportunity to exchange knowledge and ideas between health care professionals, policy makers, and manufacturers involved in the field of personal protective equipment for health care workers. This proceedings of a workshop is a factual summary of what occurred at the workshop.