Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Reissued October 15, 2020)
On April 3, 2020, the FDA issued an umbrella EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institutes of Occupational Safety and Health (NIOSH). As mentioned in CDC's strategies for optimizing respirator supply, other countries approve respirators according to country-specific standards. These devices are evaluated using methods similar to those used by NIOSH and are still expected to provide adequate protection for healthcare personnel. Non-NIOSH-approved FFRs manufactured in China that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A.
As part of the government's continuous quality assessment of these respirators, the FDA, working with CDC NIOSH, conducted additional assessments and found that some of the respirators authorized under the April 3, 2020 EUA did not meet the expected performance standards. In response, the FDA revised and reissued the EUA on May 7, 2020 to among other revisions, revise the third criterion for eligibility. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China - all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC NIOSH to determine whether the respirator meets the expected particulate filtration standards.
On June 6, 2020 the FDA further revised the Scope of Authorization of this EUA, to among other changes, further revise the third eligibility criterion, revise the second eligibility criterion, and remove decontaminated respirators from the scope of authorized products such that authorized respirators listed in Appendix A will no longer be authorized if they are decontaminated.
On October 15, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to authorize for emergency use only those respirators listed in the EUA’s Appendix A as of the date of this reissuance. Effective immediately, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. Further explanation of the revisions can be found in the Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators.
EUA Letter of Authorization - Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (Reissued October 15, 2020)
Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs
Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China (Updated October 15, 2020)
Respirator Models No Longer Authorized (Updated October 15, 2020)
Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: October 15, 2020)
The table below includes a list of non-NIOSH respirators authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.
As stated in the EUA, authorized respirators should be used in accordance with CDC's recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators.
