Previously, N95 filtering facepiece respirators (N95) used in healthcare needed approval from both the National Institute for Occupational Safety and Health (NIOSH) and the Food and Drug Administration (FDA).* 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. This exemption will decrease the regulatory burden on some respirator manufacturers, and will eliminate private costs, and expenditures required to comply with certain federal regulations. Upon publication of the final order, NIOSH and FDA entered into a Memorandum
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