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 by revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if 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 to be decontaminated.
The FDA is also reissuing the two EUAs covering imported respirators by tightening 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.