NIOSH and FDA Collaborate to Streamline Regulatory Oversight for N95 Respirators

NIOSH and FDA Collaborate to Streamline Regulatory Oversight for N95 Respirators

Subject to conditions and limitations, some N95s will be exempt from FDA premarket notification requirements, meaning that N95 manufacturers will be able to submit a single application to NIOSH rather than submitting paperwork for clearance and approval from both agencies.

The National Institute for Occupational Safety and Health (NIOSH) and the Food and Drug Administration (FDA) have agreed to collaborate in an effort to streamline regulatory oversight of N95 filtering facepiece respirators, or N95s. NIOSH and FDA will be working together to help reduce duplicative premarket processes for N95s used in healthcare.

FDA published a final order in the Federal Register on Thursday to exempt a subset of N95s intended to be used in healthcare settings from premarket notification requirements subject to conditions and limitations. Per the final order, NIOSH and FDA have entered into a Memorandum of Understanding that provides a framework for coordination and efficiency in regulatory oversight between the two agencies and outlines their mutually agreed upon review process.

Subject to conditions and limitations, some N95s will be exempt from FDA premarket notification requirements, meaning that N95 manufacturers will be able to submit a single application to NIOSH rather than submitting paperwork for clearance and 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.”

NIOSH will now evaluate the N95 manufacturer’s test data and conduct post-market audits for flammability, biocompatibility, and fluid resistance to make sure they meet relevant standards during its approval process. These evaluations were previously undertaken by the FDA.

NIOSH will begin accepting applications to put this process into practice on July 2, 2018 for manufacturers intending to submit N95 filtering facepiece respirators for approval in healthcare settings.  

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