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FDA revises emergency use authorization for certain non-NIOSH approved respirators

 

The U.S. Food and Drug Administration updated its emergency use authorization for certain non-NIOSH approved respirators with the removal of several manufacturers whose face masks failed to meet filtration efficiency performance standards.

The EUA was first issued April 3 in response to PPE shortages caused by the COVID-19 pandemic, permitting health care providers to use non-NIOSH-approved respirators as long as they are used in accordance with CDC recommendations. However, the agency issued a revised EUA May 7 after testing data from NIOSH found that some of the respirators previously listed did not meet the expected performance criteria of filtering at least 95% of particles.

In addition to revising eligibility criteria and removing previously authorized respirators, the FDA says it will increase screening of imported respirators, detain shipments of products that NIOSH has listed on its website as not meeting performance criteria and will also begin sampling respirators for further NIOSH testing to verify product filtration efficiency.

Providers are encouraged to consult the FDA’s list of non-NIOSH approved respirators and its updated list of non-NIOSH approved respirators manufactured in China for further guidance. Find more information on the revised EUA in the FDA’s FAQ for non-NIOSH approved respirators.

Assessment results of non-NIOSH approved respirators

The National Personal Protective Technology Laboratory has published the results of filter efficiency assessments on dozens of non-NIOSH approved respirators. The assessments were developed to support the availability of respirators for health care workers and other workers during the COVID-19 pandemic. The assessment results also list possible counterfeit products.

The results of any filter penetration test can only be used to provide a check of the product’s filter efficiency. Conclusions should not be made regarding equivalency to N95 products that are NIOSH approved.

View the assessment results for additional guidance on non-NIOSH approved respirators.

For the latest news, tips and resources, visit CDA’s COVID-19 information center.

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