FDA Revises EUA Criteria for Respirators Manufactured in China

In a June 6 Letter of Authorization (LoA) regarding the emergency use authorization (EUA) for non-National Institute for Occupational Safety and Health (NIOSH)-approved disposable filtering facepiece respirators manufactured in China, the U.S. Food and Drug Administration (FDA) reissued its May 7 LoA to revise the Scope of Authorization and Conditions for Authorization. As a result of the revision, many respirators authorized under the May 7 LoA no longer meet the criteria of the June 6 LoA and are no longer authorized. Appendix A lists currently authorized respirators.

According to FDA’s current criteria (Scope of Authorization), 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. The respirator meets one of the following criteria:
   1. Has a registration certification, reflecting regulatory authorization, under the jurisdiction of the Chinese National Medical Products Administration (NMPA) and that is given by an appropriate provincial or municipal authority (certification must be for a medical protective mask as short-term emergency certifications do not qualify), and that has been authenticated and verified by FDA.
   2. Conforms to Personal Protective Equipment (PPE) Directive 89/686/EEC (for those placed into distribution before April 21, 2019) or that 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 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 May 7 LoA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.

Under the June 6 LoA, a respirator previously authorized in the May 7 LoA because it meets criterion 3 above is no longer authorized if it has been sampled by the FDA, tested by NIOSH via a modified version of STP TEB-SPR-APR-0059 and has results according to NIOSH that indicates one or more of the sampled respirators has a filtration efficiency of less than 95%. View a list of respirator models removed from Appendix A and no longer authorized.

In addition, the FDA revised the Conditions of Authorization of the May 7 LoA such that authorized respirators listed in Appendix A will no longer be authorized if such respirator has been decontaminated.

For a complete list of the requirements for authorized respirators, please see the full June 6 LoA.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.