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FDA Reissues EUA For Certain Filtering Face-piece Respirators Made In China

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The Food and Drug Administration has reissued Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) made in China.

The FFRs are approved by neither the Centers for Disease Control and Prevention's (CDC) or by the National Institute for Occupational Safety and Health (NIOSH).

As per the EUA, which was granted on June 6, a respirator was authorized if it met any of three predetermined eligibility criteria. However, as this EUA no longer includes the three eligibility criteria, it will not be added to the list of authorized respirators, called Appendix A.

According to the FDA, as there is a shortage of FFRs, the regulator is continuing the emergency use authorization of respirator models that are already included in Appendix A of this reissued EUA.

"Since the beginning of the COVID-19 public health emergency, we have taken appropriate actions to support the personal protective equipment needs of our health care personnel by issuing EUAs," said Suzanne Schwartz, M.D. M.B.A., Director of the FDA's Office of Strategic Partnerships and Technology Innovation in the Center for Devices and Radiological Health.

She added, "As part of our continuing work to meet the demands of this public health emergency, we undertook and completed a shortage assessment and concluded that reissuing this EUA was appropriate to reflect the current U.S. demand for these products."

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