FDA Revokes Emergency Use Authorization (EUA) for Battelle Decontamination System
Today, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel.
The FDA revoked the EUA in response to Battelle's request for voluntary withdrawal of the authorization. In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities.
As a reminder, decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or any new respirators. Moreover, earlier this month, the FDA issued a letter to health care providers recommending transitioning from use of decontaminated disposable respirators.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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