Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and Health (NIOSH). The new EUA on non-NIOSH respirators from China adds new conditions for authorization and supersedes the agency’s prior EUA from April 3, 2020. According to FDA, the revision was “in response to questions and concerns that have been received by FDA” and led the agency to conclude that revision “is appropriate to protect the public health or safety”.

Under the earlier EUA, a disposable non-NIOSH-approved respirator manufactured in China was eligible for authorization if it met any one of the following three criteria:

1. It is manufactured by an entity that holds one or more NIOSH approvals for other models of filtering facepiece respirators (FFRs) produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA;
2. It has a regulatory authorization under a jurisdiction other than China that can be authenticated and verified by FDA; or
3. It demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA.

FDA has now revised its list of authorized respirators from China by removing all Chinese respirators that were authorized based on the third criteria, i.e., meeting certain laboratory testing. The new EUA substantially changes both the second and third criteria. Under the new EUA, a non-NIOSH-approved respirator from China may be authorized if:

1. It is manufactured by an entity that holds one or more NIOSH approvals for other models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA; or
2. It 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; or
3. 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) TEB-APR-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.

In addition, the new EUA only allows manufacturers to request authorization; previously importers could also submit a request to add respirators to the list of authorized respirators. The new EUA also provides a process that FDA will use in the future to remove products from the list of authorized respirators. As part of the new process, FDA agrees to provide advance notice to manufactures of respirators that do not meet quality standards or authorization conditions, such as with labeling and reporting. FDA then will “work with the manufacturer regarding the planned removal” of the product from the list of authorized respirators. FDA advises that it will keep a list of respirators removed using this new process on its website.

As a summary, four main changes to the EUA for Chinese respirators have occurred:

• A respirator having a “Chinese National Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal authority” will suffice to meet the second criteria. In the earlier EUA, regulatory authorization had to be from jurisdictions “other than China.”
• FDA will no longer authorize Chinese respirators on the basis of independent test laboratory results. Respirators previously authorized based on testing criteria can be relisted if the manufacturers submit such respirators to NIOSH for testing within 45 days and the respirators meet filtration requirements.
• Only manufacturers, not importers, can request authorization for Chinese respirators.
• FDA now provides a process for removing an authorized product after listing that provides prior warning.