NIOSH, FDA Partner to Harmonize Regulatory Oversight of N95s in Healthcare

Published December 6, 2017

​In November, the Food and Drug Administration and NIOSH signed an agreement intended to streamline and harmonize regulatory oversight of N95s. The memorandum of understanding seeks to reduce conflicting and duplicative premarket processes for surgical N95 and N95 filtering facepiece respirators used in healthcare settings. The MOU is also intended to help stakeholders understand the necessary steps for satisfying applicable regulatory requirements. The agencies hope to eliminate confusion created by the distinction between NIOSH approval and FDA clearance for these devices.

According to NIOSH, the agreement will help ensure the availability of safe and effective respirators, particularly during times of increased demand.According to FDA, the MOU will not be effective unless both surgical N95 and N95 filtering facepiece respirators are exempt from a pre-market notification. Known as a 510(k) clearance, a pre-market notification contains information used by FDA to determine whether a new device is “substantially equivalent” to a legally marketed device that does not require premarket approval. A Federal Register notice explains that FDA has determined that surgical N95 and N95 filtering facepiece respirators “no longer require a 510(k) to provide reasonable assurance of safety and effectiveness.”

FDA’s proposal has a comment period that ends on Jan. 29, 2018. For further details, see the Federal Register notice and the MOU.

Related: Earlier this year, the National Academies of Sciences, Engineering, and Medicine published the proceedings of an August 2016 workshop on the integration of the two federal agencies’ processes to certify and approve N95 respirators for healthcare settings.