On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second 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 viewed here.

The below alert provides an overview of the guidance.

Overview

In response to concerns received by the FDA following the issuance of the April 3 EUA, the FDA concluded that revising the EUA was appropriate to protect public health and safety under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and subsequently revised and reissued the May 7, 2020, EUA on June 6. This is a second amendment to the guidance, which was originally dated April 3. Specifically, the FDA revised the April 3 EUA to provide clarification and address concerns about substandard products.

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

There are five main revisions to the May 7 EUA:

1. The FDA revised the second eligibility criterion to limit the jurisdictions to only certain CE mark (European Economic Area certification mark) FFRs in addition to respirators that have a Chinese National Medical Products Administration (NMPA) certification (which was included in the May 7, 2020, revision).
2. The FDA revised the third criterion such that a respirator model that is sampled by the FDA and tested by NIOSH, and that has results according to NIOSH that indicates one or more of the 30 sampled respirators has a filtration efficiency of less than 95 percent, is no longer authorized. The 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 FDA revised the Scope of Authorization to remove Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China that have undergone decontamination. As such, previously authorized respirators that were reusable after having been decontaminated are no longer authorized under this EUA. They may, however, be authorized under an individual decontamination system EUA.
4. The FDA added Conditions of Authorization to require samples for testing when requested by the FDA and prevent distribution of shipments that fail testing.
5. The FDA added Conditions of Authorization regarding printed materials, advertising, and promotion under Section 564(e)(4) of the Act.

Respirators Eligible for Authorization Under This EUA

A disposable non-NIOSH-approved respirator manufactured in China is authorized under this EUA if it meets any of the below criteria:

1. The respirator is manufactured by an entity that holds one or more NIOSH approvals, that has been verified by the FDA for FFRs, and that is produced by the NIOSH approval holder in accordance with the applicable standards of authorization in another country.
2. The respirator either:
   1. Has a registration certification reflecting regulatory authorization under the jurisdiction of the NMPA that is given by an appropriate provincial or municipal authority and that has been authenticated and verified by the FDA, or
   2. Conforms to Personal Protective Equipment (PPE) Directive 89/686/EEC (for those placed into distribution before April 21, 2019) or conforms to PPE Regulation (European Union (EU)) 2016/425 (for those placed into distribution after April 21, 2019), as evidenced by a CE mark, and the CE mark has been authenticated and verified by the FDA.
3. The respirator 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) TEB-APR-STP-0059 within 45 calendar days of the date of issuance of the May 7, 2020, letter; and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent. A respirator authorized under this EUA because it meets the criterion in the previous sentence is no longer authorized if it has been sampled by the FDA, tested by NIOSH via a modified version of STP TEB-APR-STP-0059, and has results according to NIOSH that indicate one or more of the 30 sampled respirators has a filtration efficiency of less than 95 percent.

Please note that respirators that were previously authorized under the April 3 EUA and removed due to the May 7 revision have a 45-day window to be re-added to the list of authorized respirators in Appendix A. The deadline to be re-added is June 21.

Respirators authorized under the third criterion will have 30 respirators sampled by the FDA using a modified version of NIOSH's Standard Test Procedure (STP) TEB-APR-STP-0059.

Removal from Appendix A

The FDA may remove a product that has been added to Appendix A if the FDA believes that the product no longer meets the criteria or scope of authorization. The FDA will provide the manufacturer with advance notice, and will work with the manufacturer regarding the removal.

Promotional Materials

All advertising and promotional materials need to be consistent with the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations. No advertising or promotional materials may represent or suggest that the authorized product is approved by NIOSH.