What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China.
As discussed in our prior Alert, FDA had previously issued an Emergency Use Authorization (EUA) for non-NIOSH-approved respirators manufactured in China. Our prior Alert on that April 3 EUA can be found here
. Under that original EUA, respirators listed in Appendix A were authorized for use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations. As with so many other COVID-related matters, however, FDA’s thinking on this issue has since changed.
Subsequent to its issuance of that April 3 EUA, FDA received questions and concerns about its approach. Thus, on May 7, FDA reissued that prior EUA with four significant revisions.
Each of those revisions is summarized below.
Revision No. 1
Respirators that were previously included in FDA’s List of Authorized Respirators at Appendix A on the basis of their having purportedly met the test report eligibility criterion have been removed. These respirators are no longer authorized unless the respirator satisfies one of the criteria listed in the May 7 reissued EUA.
Specifically, a respirator must now satisfy at least one of the following to be deemed eligible for importation and distribution per the test-report criterion:
- The mask must have 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 May 7 EUA. The results of that NIOSH testing must indicate a minimum and maximum filtration efficiency of greater than or equal to 95 percent.
- Important to this new eligibility criterion, FDA notes that it will sample respirators under this criterion from those lots of respirators that have already been imported. FDA further notes that it will work with manufacturers that have not shipped respirators to the U.S. by May 7 (i.e., date of EUA reissuance) to sample respirators once they arrive at a U.S. port of entry to determine whether this criterion is satisfied;
- The mask must be manufactured by an entity that holds one or more NIOSH approvals for other models of respirators manufactured according to the applicable standards of authorization in other countries that can be verified by FDA; or
- The mask has a regulatory authorization under a jurisdiction, including the Chinese Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal regulatory authority, that can be authenticated and verified by FDA.
Revision No. 2
The NMPA registration certification requirement referenced in the bullet point above is a revision to this criterion as provided in the April 3 EUA. That criterion had been that the mask have “a regulatory authorization under a jurisdiction other than China” that could be authenticated and verified by FDA.”
Revision No. 3
Only manufacturers can request to be added to Appendix A. Importers had also previously been allowed to make such a request.
Revision No. 4
FDA describes the process that it will use to remove respirators from Appendix A if FDA has reason to believe that the respirator is no longer eligible for authorization. FDA states that it will provide the manufacturer advance notice, and work with the manufacturer regarding the planned removal of the product from the list of Authorized Respirators at Appendix A. In addition to removal from Appendix A, the product will be placed on a list maintained on FDA’s EUA webpage.
Customs Instructions for Declaring Under an EUA
CBP has not changed its instructions for filing since the April 21, 2020 instructions were issued, as described in our April 22 Alert re: the importation of face masks generally.
CBP has issued some guidance on its COVID 19 information website for consumers to consider when buying products on line.
Additionally, in CSMS #42635055, CBP advises importers:
"If a request for documents is received from FDA, filers and/or importers are strongly encouraged to submit product labeling along with regularly submitted entry documents (commercial invoice, packing list, waybill, etc.). Submission of labeling will help expedite the admissibility process during this pandemic.
Labeling along with entry documents should be submitted electronically via the FDA Import Trade Auxiliary Communication System (ITACS). ITACS functionality can be accessed here. This includes checking statuses, providing requested documentation and location of goods electronically, and checking the estimated laboratory analysis completion dates for lines which have been sampled."
As made evident on nearly a weekly basis, FDA’s regulation of importation and distribution of PPE and other medical devices to address the needs of the COVID-19 pandemic continues to evolve on a frequent basis. We will continue to watch the space and update accordingly.
 In addition to the criteria discussed in this Alert, FDA also reiterates that respirators must “at a minimum” comply with the labeling requirements A and B under the Conditions of Authorization in the EUA. This is consistent with its April 3 EUA. Specifically, per requirement A, the manufacturer of an authorized respirator must publish the intended use and other instructions on their website in English, and notify FDA of the company website address that meets this condition. FDA must also be notified of any changes to that website. Per requirement B, the manufacturer of an authorized respirator must include an English-version letter for distribution to each end user facility that receives the authorized respirator. That letter must include the respirator’s manufacturer, model, intended use, manufacturer’s website, etc.
 For point of reference, this is the same criterion as provided for in the April 3 EUA. There have been no changes made to it in the May 7 reissued EUA.