USA: FDA reissues Emergency Use Authorizations, revising which respirators can be decontaminated

June 25, 2020

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:

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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