USA: FDA reissues Emergency Use Authorizations, revising which respirators can be decontaminated
The Food and Drug Administration (FDA) has reissued Emergency Use Authorizations (EUAs) to specify which respirators are appropriate for decontamination.
Among other things, the FDA has reissued the EUAs for:
- Non-NIOSH-Approved Filtering Facepiece Respirators (FFRs) manufactured in China – authorized respirators listed in Appendix A will no longer be authorized if decontaminated
- Multiple decontamination systems – where applicable, the decontamination of respirators manufactured in China is no longer authorized. In addition, only non-cellulose respirators that do not have an exhalation valve will be authorized for decontamination, provided they are either NIOSH-approved or are authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators.
Decontaminated respirators should only be used when the following are not available: new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators.
Follow the link to review the guidance: Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse
How TSG can help
TSG’s consultants have been guiding companies throughout the COVID-19 pandemic. We can coordinate the approval of N95 respirators with regulatory agencies. We can also assist in identifying appropriate tests for FFRs in order to fulfill data requirements as well as develop and review labels and label claims.
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