Emergency Use Authorizations | FDA

Emergency Use Authorizations | FDA

New Emergency Use Authorization (EUA) to Decontaminate Respirators

On April 9, 2020, the U.S. Food and Drug Administration granted an emergency use authorization to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide to decontaminate compatible N95 or N95-equivalent respirators. Hydrogen peroxide sterilization is a low temperature sterilization process that utilizes hydrogen peroxide vapor. The vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces. The STERIS V-PRO Decontamination Cycle is capable of processing 10 respirators at one time through a process that takes approximately 28 minutes to complete. Each respirator can be processed up to 10 times for single-user reuse. This EUA is estimated to support decontamination of approximately 750,000 N95 respirators per day in the U.S.

Learn More Questions? If you have questions about this EUA, email CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.