Washington — Manufacturers of certain N95 respirators will be able to submit a single application to NIOSH, rather than to both the Food and Drug Administration and NIOSH, before marketing their product to the health care industry, according to an FDA final order published in the May 17 Federal Register.
Previously, all N95 filtering facepiece respirators designed for use in health care needed clearance or approval from both agencies. The change is “a collaborative effort to harmonize regulatory oversight of [N95s],” states a NIOSH press release, which adds that NIOSH and FDA “have joined forces to help reduce duplicative premarket processes.”
On July 2, NIOSH will start accepting applications to begin implementing the process for manufacturers that intend to submit N95s for health care setting approval. As before, respirators reviewed with this process are to be used in accordance with OSHA respiratory protection requirements.
The agencies entered into a Memorandum of Understanding upon publication of the final order that “provides a framework for efficient and coordinated regulatory oversight between FDA and NIOSH and outlines the agencies’ mutually agreed upon review process.”
According to the MOU, during the approval process, NIOSH will grade manufacturers’ test data for biocompatibility, flammability and fluid resistance on their adherence to relevant standards. Those tasks previously were FDA’s responsibility. NIOSH also will perform post-market audits that test for flammability and fluid resistance in a sample of products to ensure they conform to approved conditions.
