One type of respirator routinely used to protect both the patient and healthcare provider from the transfer of microorganisms, body fluids, and particulate material is known as an N95 respirator. N95s are single-use, disposable respiratory protective devices.
FDA and CDC’s National Institute for Occupational Safety and Health (NIOSH) share regulatory oversight of N95 respirators. In a final order released on May 16, 2018, FDA is exempting certain N95s from premarket notification [510(k)] requirements, and executing a Memorandum of Understanding with NIOSH. The final order and MOU streamline the regulation of N95s to help manufacturers easily identify, understand, and work to meet marketing requirements, and help ensure the availability of safe and effective medical products, particularly during times of increased demand, such as a public health emergency.
This final action will also decrease regulatory burden on the medical device industry and will eliminate costs required to comply with certain Federal regulations.