NIOSH and FDA Collaboration Streamlines Regulatory Oversight for N95 Filtering Facepiece Respirators

Press Contact: Stephanie Stevens (202) 245-0641

New streamlined review process will reduce regulatory burden for some respirator manufacturers

In a collaborative effort to harmonize regulatory oversight of N95 filtering facepiece respirators, or N95s, the National Institute for Occupational Safety and Health (NIOSH) and the Food and Drug Administration (FDA) have joined forces to help reduce duplicative premarket processes for N95s used in healthcare settings.

On May 17, 2018, FDA published a final order in the Federal Register to exempt a subset of N95s intended for use in healthcare from premarket notification requirements subject to conditions and limitations. Upon publication of the final order, NIOSH and FDA entered into a Memorandum of Understanding (MOU) that provides a framework for efficient and coordinated regulatory oversight between FDA and NIOSH and outlines the agencies’ mutually agreed upon review process.

Subject to the conditions and limitations of exemption outlined in the final order, certain N95s will be exempt from FDA premarket notification requirements which means that manufacturers will now be able to submit a single application to NIOSH, rather than applications to both FDA and NIOSH prior to marketing their product. Previously, all N95s intended for use in healthcare needed clearance/approval from both agencies.

“The FDA action is the first step in streamlining an approval process that was redundant and burdensome,” said Maryann D’Alessandro, director of NIOSH’s National Personal Protective Technology Laboratory. “NIOSH will continue to ensure these respirators provide the expected performance levels and are safe for their intended use.”

In accordance with the MOU, NIOSH will now evaluate the manufacturer’s test data for biocompatibility, flammability, and fluid resistance for conformity to relevant standards during its approval process, tasks previously performed by the FDA.

As part of the conformity assessment process, NIOSH will conduct post-market audits that will involve tests for flammability and fluid resistance for a sample of products in accordance with the appropriate federal and consensus standards. This will ensure the products continue to conform to the approved conditions.

NIOSH will begin accepting applications to implement this process on July 2, 2018 for those manufacturers intending to submit N95 filtering facepiece respirators for approval in healthcare settings. Consistent with current practices, respirators reviewed under this process are intended to be used in accordance with Occupational Safety and Health Administration (OSHA) respiratory protection standard requirements.

NIOSH has published related research on respirator filtration on the NIOSH Science Blog and fluid resistance in the American Journal of Infection Control.

NIOSH is responsible for approval of N95s intended for occupational use. The authority is granted to NIOSH in accordance with standards established in 42 CFR Part 84. NIOSH also addresses quality assurance requirements for the manufacturing of respiratory protective equipment.

For more information on the NIOSH respirator approval program, visit the NIOSH website.

NIOSH is the federal institute that conducts research and makes recommendations for preventing work-related injuries and illnesses. More information about NIOSH can be found at www.cdc.gov/niosh.