Regulatory Focus™ > News Articles > 2020 > 10 > FDA reissues Chinese respirator EUA, but freezes new additions

FDA reissues Chinese respirator EUA, but freezes new additions

Posted 16 October 2020 | By Kari Oakes 

FDA reissues Chinese respirator EUA, but freezes new additions

The emergency use authorization (EUA) for certain types of filtering face-piece respirators has been reissued by the US Food and Drug Administration (FDA) as the public health emergency of the COVID-19 pandemic continues. However, only respirators already authorized under the document's earlier version will be covered under the reissued umbrella EUA.
The umbrella EUA was extended for certain filtering face-piece respirators made in China and not approved by the National Institute for Occupational Safety and Health (NIOSH).
However, FDA will no longer be adding to the list of respirators covered by the EUA and contained in an appendix to the EUA: “FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. Only those respirators listed in Appendix A as of the date of this reissuance are authorized by this EUA,” said the agency in an updated question and answer webpage regarding EUAs for non-NIOSH-approved respirators.
The reissued EUA no longer includes the three predetermined eligibility criteria contained in the June 2020 versions of the authorizations, precluding the addition of new respirators to the appended list.
FDA conducted a respirator shortage assessment “to understand current product availability for both NIOSH-approved N95s and KN95 respirators and use practices for each,” said the agency in its announcement of the reissuance. Adoption of the KN95 respirators that meet the conditions of the EUA has been slow in health care environments, and many such products from China are “sitting in warehouses unused.”  At the same time, said FDA, NIOSH-approved N95 production and approvals are on the increase.
Options for manufacturers of non-NIOSH-approved respirators from China include marketing the respirators as face masks for the general public and for health care personnel as source control, rather than personal protective equipment (PPE). This category of masks is covered by a separate EUA.
Also, if a product is marketed for a non-device use, such as for use in construction, FDA device marketing authorization or clearance is not required, pointed out the agency in its answer.
FDA letter


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Tags: coronavirus, FDA, US

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