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Respiratory Protective Devices Used in Healthcare

March 2014
NIOSH Docket Number 272, CDC-2014-0005

Respiratory protective devices (RPDs) that are approved by the National Institute for Occupational Safety and Health (NIOSH) and also cleared by the Food and Drug Administration (FDA) as medical devices are widely used in surgical and non-surgical healthcare environments. There are reports that other NIOSH-approved RPDs that are not FDA-cleared medical devices are also being used to protect healthcare workers from inhalation hazards. The desirability of NIOSH incorporating additional requirements and tests in its 42 CFR Part 84 respirator approval process to parallel the protections in the FDA clearance process for Surgical N95 Respirators in surgical and non-surgical healthcare environments has been mentioned during broad-based and cross-agency discussions for future pandemic events as well as day-to-day use in healthcare settings.

NIOSH could augment the existing requirements and tests of the 42 CFR Part 84 conformity assessment process to incorporate requirements included in the FDA clearance process, such as fluid resistance and flammability. Both FDA and NIOSH require demonstration of filtration performance. The current NIOSH filtration testing requirements use non-biological aerosol based on the assumption that all particles, biological or non-biological, behave according to the same principles of aerosol physics for filtration: that is, by impaction, interception, diffusion, and electrostatic attraction. NIOSH is seeking public comment with available supporting data that either validates or disproves this assumption.

To view the notice and related materials, visit and enter CDC-2014-0005 in the search field and click "Search."

Federal Register Notice

Public Comment Period

Comments will be accepted until 5:00 p.m. EST on April 30, 2014.

Written comments, identified by CDC-2014-0005 and docket number NIOSH-272, may be submitted by any of the following methods:

  • Federal rulemaking portal: Follow the instructions for submitting comments.

    Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to

  • Mail: NIOSH Docket Office
    Robert A. Taft Laboratories
    4676 Columbia Parkway
    Cincinnati, OH 45226