May 11, 2020

FDA Revises EUA Criteria for Respirators Manufactured in China

In a May 7 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its April 3 LoA with revised eligibility EUA criteria for non-NIOSH-approved disposable filtering facepiece respirators manufactured in China. As a result of the revision, Appendix A currently lists only 14 Chinese manufacturers (down from a peak number of approximately 80 manufacturers prior to this recent criteria change) that can supply authorized respirator models. FDA changed the eligibility criteria due to manufacturers’ products failing to demonstrate a minimum particulate filtration efficiency of 95 percent.

According to FDA’s current criteria, as outlined in the May 7 LoA, in order to be eligible for authorization under the EUA, a respirator must meet one of the following criteria:

  1. Respirator is manufactured by an entity that holds one or more NIOSH approvals for other models of respirators produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA.
  2. Respirator has a regulatory authorization under a jurisdiction, including the Chinese National Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal regulatory authority, that can be authenticated and verified by FDA.
  3. Respirator was previously listed in Appendix A under the April 3 LoA as an authorized respirator because it demonstrated acceptable performance to applicable standards as documented by test reports, has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEBAPR-STP-0059 within 45 calendar days of the date of issuance of this EUA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.

If a respirator meets one of the above current criteria, FDA will add the respirator to Appendix A as an authorized respirator once FDA confirms eligibility criteria are met. As noted, FDA has removed from Appendix A respirators that fail to meet the above criteria. FDA also states that it may remove respirators from Appendix A if FDA has reason to believe that the respirator is no longer eligible for authorization. Further, FDA will no longer allow importers to submit requests to add respirators to Appendix A.

Note that in the original third criterion in the April 3 LoA respirators eligible for authorization “demonstrate acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA.” The current criterion 3, as shown above, mandates NIOSH testing within 45 days of the EUA, with results indicating a minimum and maximum filtration efficiency greater than or equal to 95 percent.

For a full list of the requirements for authorized respirators, please see the full May 7 LoA.

Please note the revised May 7 LoA regarding non-NIOSH approved respirators made in China does not affect the previous March 28 LoA for Non-NIOSH-Approved Imported Respirators.

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