Agencies Agree to New Approval Process for N95 Respirators in Healthcare
On May 17, NIOSH and the Food and Drug Administration began coordinating regulatory oversight of surgical N95 respirators and N95 filtering facepiece respirators, as outlined in a memorandum of understanding between the two agencies.  Previously, manufacturers of N95s for use in healthcare were required to submit applications for approval of their devices to both NIOSH and FDA. Under a new process described in the MOU, manufacturers are required to submit only one application, to NIOSH, which will ensure that the devices provide the expected performance and are safe for their intended use, according to a NIOSH press release. NIOSH will also assume responsibility for evaluating manufacturers’ test data for biocompatibility, flammability, and fluid resistance for conformity to relevant standards. These tasks were previously performed by FDA. According to the MOU, the coordination between NIOSH and FDA is intended to eliminate duplicative actions, streamline regulatory oversight, and help ensure the availability of N95s during times of increased demand. In a related development, FDA published a final order in the May 17 Federal Register exempting certain N95s from “pre-market notification,” a process through which FDA determines whether a new device is “substantially equivalent” to a legally marketed device that does not require premarket approval. According to the final order, FDA has determined that surgical N95 and N95 filtering facepiece respirators “no longer require [pre-market notification] to provide reasonable assurance of safety and effectiveness” provided that the respirators have NIOSH approval and that NIOSH has determined the devices do not exceed threshold evaluation criteria agreed upon by FDA and CDC.