In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel. For example, the FDA has learned from the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) testing that authorized respirators manufactured in China may vary in their design and performance. As such, the FDA has determined that the available information does not support the decontamination of these respirators and has accordingly revised the relevant EUAs.
