On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National Institute for Occupational Safety and Health (NIOSH) standards. The official guidance can be located here.

This alert provides an overview of the guidance.

Overview

In response to concerns received by the FDA since the issuance of the April 3 EUA and concluding that revising this EUA was appropriate to protect the public health and safety under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA revised and reissued the April 3, 2020 EUA on May 7. Specifically, the FDA revised the April 3 EUA to clarify and to address concerns about sub-standard products.

This revised EUA does not affect the previous March 28 EUA for Non-NIOSH-Approved Imported FFRs (originally issued on March 24), which authorizes, in part, the emergency use of certain imported disposable FFRs that are not NIOSH-approved and excluded those manufactured in China.

The FDA has re-issued this EUA with certain revisions to authorize disposable respirators manufactured in China that meet certain criteria, including criteria concerning additional validation and review by the FDA to confirm the respirator's authenticity.

Revisions to the EUA for Non-NIOSH Approved Imported FFRs Made in China

There are four main revisions to the April 3 EUA.

1. The third criteria in the original April 3 letter of authorization has been revised and as a result, all respirators that were authorized under the test report eligibility criterion have been removed from the list of authorized respirators in Appendix A and are therefore no longer authorized unless the respirator is authorized under one of the criteria as outlined in the Scope of Authorization (Section II) of the re-issued EUA.
2. The Chinese National Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal regulatory authority that is authenticated and verified by the FDA has been added to the second criterion.
3. The EUA is being revised so that only manufacturers can request to be added to Appendix A. Importers will no longer be allowed to submit a request to add an FFR to Appendix A.
4. The FDA has amended the Scope of Authorization (Section II) to describe a process the FDA will use in removing respirators from Appendix A if the FDA has reason to believe that the respirator is no longer eligible for authorization.

Requirements for FFRs Previously Authorized Under the Third Criterion of the April 3, 2020 EUA

The third criteria in the April 3 EUA requirement was: "Demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA."

This criteria is now outdated, and the FDA replaced it with, "It was previously listed in Appendix A under the April 3, 2020 letter of authorization 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."

For respirators which received an EUA based on the outdated criteria, within 45 calendar days of the reissuance of the EUA, the FDA will need to be provided with:

• Contact information for the manufacturer (name, address, contact person, phone number, and email), model number, and a copy of the product labeling for the respirator you want authorized
• A weblink which displays the results of your NIOSH test report
• A list of authorized importer(s) including contact information (name, address, contact person, phone number, and email)
• An estimate of the number of respirators you are planning to import during the public health emergency.

Requirements for FFRs Currently Under FDA Review for an EUA Application

If a respirator's request for addition to Appendix A includes documentation that supports meeting eligibility criterion one (i.e., holds one or more NIOSH approvals for other models of respirators) or criterion two (i.e., the model has a regulatory authorization under a jurisdiction that can be authenticated and verified by the FDA), the request will continue to be reviewed to determine if your respirator(s) meets one of these criteria.

If the submission does not meet either of these criteria, as described in the May 7 Emergency Use Authorization, the request will not be granted and the respirator(s) will not be added to Appendix A.

Contact

If you have any questions about the revised EUA, email DICE@fda.hhs.gov.