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HEALTHCARE
NIOSH, FDA Partner to Harmonize Regulatory Oversight of N95s in Healthcare
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.”
In February 2017, the National Academies of Sciences, Engineering, and Medicine published the proceedings of a 2016 workshop on the integration of the two agencies’ processes to certify and approve N95 respirators for healthcare settings.