FDA/NIOSH agreement on N95 regulation

The FDA and the CDC National Institute for Occupational Safety and Health (NIOSH) signed a Memorandum of Understanding (MOU) to simplify regulation of N95 respirators used in healthcare settings. Federal law requires regulation of respiratory protective devices by both FDA, under the Federal Food, Drug, and Cosmetics Act, and NIOSH, under the Public Health Service Act. Under the MOU, NIOSH will evaluate respirators first, and if the devices meet the NIOSH threshold standards they will be exempt from FDA premarket approval requirements. Read the FDA notice and the MOU.