https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reissues-emergency-use-authorizations-revising-which-types?utm_campaign=2020-06-07%20Certain%20Respirators%20Are%20No%20Longer%20Authorized%20to%20be%20Decontaminated&utm_medium=email&utm_source=Eloqua

Certain Respirators Are No Longer Authorized to be Decontaminated for Reuse

In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the U.S. Food and Drug Administration (FDA) is reissuing certain Emergency Use Authorizations (EUAs) to revise which respirators are authorized for decontamination by certain decontamination systems. The FDA has reissued the Emergency Use Authorizations (EUAs) for: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China. The Scope of Authorization has been revised to state that authorized respirators listed in Appendix A are no longer authorized if they are decontaminated. Multiple decontamination systems to state that these decontamination systems are no longer authorized to decontaminate respirators manufactured in China, where applicable, and are now only authorized to decontaminate non-cellulose respirators that do not have an exhalation valve and that are either authorized in the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA or that are authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. The FDA is also reissuing the two EUAs covering imported respirators by tightening other criteria in the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China as well as in the Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators .

Read More Questions? If you have questions about Emergency Use Authorizations related to decontamination systems and respirators, contact the Division of Industry and Consumer Education .