Integration of FDA and NIOSH Evaluation Processes of Respiratory Protective Devices for Health Care Workers: A Workshop

When: August 1, 2016 (8:30 AM Eastern)
Where: Keck Center (100) • 500 Fifth St. NW, Washington, DC 20001

Topics Biomedical and Health Research, Health Care Workforce, Public Health
Activity: Standing Committee on Personal Protective Equipment for Workplace Safety and Health
Board: Board on Health Sciences Policy

An ad hoc committee will plan and conduct a public workshop to explore the current state of practices related to the evaluation of N95 respiratory protective devices (RPDs).

The Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating RPDs for health care workers. A NIOSH approved filtering facepiece respirator is a type of RPD that covers the user’s airway (nose and mouth). A subset of RPDs intended for use in healthcare settings to prevent transmission of microorganisms, namely NIOSH-approved surgical N95 respirators, are also reviewed by FDA as Class II medical devices. The distinction between NIOSH approval and FDA clearance may create confusion among healthcare delivery organizations and end users. In order to provide clarity, NIOSH and FDA are considering streamlining the approach for regulatory oversight for N95s intended for use in healthcare settings. Under a streamlined approach, NIOSH would determine whether the N95 FFR receives approval based on specific criteria agreed upon by the agencies. The evaluation of flammability, fluid resistance, and biocompatibility on the final finished N95 FFR are new assessments for NIOSH as they have historically been performed by manufacturers and submitted for FDA review as a part of the agency’s 510(k) premarket notification.

This workshop will explore the strengths and limitations of several current test methods as well as identify ongoing research and research needs.

This workshop will provide the opportunity to exchange knowledge and ideas between professionals, policy makers, and manufacturers involved in the field of personal protective equipment for healthcare worker with expertise in N95 RPDs intended for use in healthcare settings.

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