New FDA Order to Ease the Regulatory Burden on N95 Mask Manufacture

The US Federal Drug Administration (FDA), has published a final order to exempt a subset of N95 masks 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 of Understanding (MOU) that provides a framework for efficient and coordinated regulatory oversight between FDA and NIOSH and outlines the agencies’ mutually agreed upon review process.

As of July 2, 2018, NIOSH will begin accepting applications to implement this process for those manufacturers intending to submit N95 filtering facepiece respirators for use in healthcare. Consistent with current practices, respirators reviewed under this process are intended to be used in accordance with Occupational Safety and Health Administration (OSHA) respiratory protection standard requirements.

This FDA action affects the NIOSH approval process and related activities for NIOSH-approved N95 respirators intended for use in healthcare:

  • Redundant actions between the two agencies will be eliminated.
  • Manufacturers will only have to submit an application to one agency (NIOSH), rather than two (NIOSH and FDA).
  • NIOSH will continue to ensure these devices provide the expected performance levels and are safe for their intended use.
  • NIOSH will now evaluate the manufacturer’s test data for biocompatibility, flammability, and fluid resistance for conformity to relevant standards during its approval process, tasks previously performed by the FDA.

The conformity assessment process will include post-market audits that will involve conducting required tests, including flammability and fluid resistance. NIOSH will conduct those tests for a sample of products in accordance with the appropriate federal and consensus standards to ensure the products continue to conform to the approved conditions.

Under the MOU, the FDA and NIOSH will continue to monitor the conformity assessment approach to determine if any changes are needed to best align with the PPE Conformity Assessment Framework and continue to streamline and harmonize each agency’s processes where overlapping responsibilities exist.