May 14, 2020

FDA Reissues Emergency Use Authorization for Respirators from China

On May 7, the Food and Drug Administration reissued its April 3 Emergency Use Authorization governing the use of non-NIOSH-approved, Chinese-manufactured filtering facepiece respirators for healthcare settings in the U.S. The change revokes authorization for several respirator models previously approved for emergency use.

Suzanne Schwartz, deputy director of FDA’s Office of Strategic Partnerships and Technology Innovation, explained the rationale behind the agency’s actions during a NIOSH-sponsored webinar held May 7. According to Schwartz, FDA recently learned that several approved respirators had failed to meet expected performance standards for filtration efficiency when tested by NIOSH.

Because of FDA’s concerns about respirators fraudulently marketed as KN95—a class of respirator made in China that meets respirator performance standards considered to be equivalent to NIOSH standards—the agency did not include Chinese-made respirators in a March 28 EUA specifying products made in countries outside the U.S. that healthcare facilities could use to meet the need for respiratory protection.

Recognizing that the March 28 EUA was not sufficient to provide enough respirators to meet demand, FDA issued its April 3 EUA covering Chinese-made filtering facepiece respirators. The April 3 EUA stated that FFRs originating from China had to meet one of three criteria to be approved for emergency use: either the manufacturer must be a current NIOSH approval holder; the product must have regulatory authorization in a jurisdiction other than China; or the product must have been tested by an independent laboratory and accredited to international standards, with test reports that demonstrated performance standards have been met. Respirator models that met one of these criteria were listed in Appendix A of the April 3 EUA.

Meanwhile, beginning in April, NIOSH began testing samples of respirators available on the market according to a modified version of the agency’s protocol for filtration efficiency testing. NIOSH found that many Chinese-made respirators approved for use under the criterion for laboratory testing failed to meet the expected filtration efficiency of at least 95 percent when tested according to the NIOSH protocol. NIOSH notified FDA, and in response, FDA reissued the EUA for Chinese-made respirators with the third criterion eliminated. The change resulted in more than 70 products being removed from Appendix A.

Schwartz said the agency’s action was made “out of an abundance of caution.” While respirators that do not meet the standard for filtration can no longer be distributed as respirators in the U.S., they may be relabeled as source control, she said.

Visit the FDA website for the agency’s May 7 (PDF) and March 28 (PDF) EUAs, the updated Appendix A (PDF), and a list of the products removed from Appendix A (PDF). A recording of the NIOSH webinar, which addresses concerns related to purchasing respirators manufactured abroad, is available on YouTube.