May 8, 2020
The changes include:
• Criteria for authorization based on acceptable performance to standards documented by independent laboratory testing
• The ability of importers to apply for the EUA and directing manufacturers to provide a list of authorized importers
• Adding recognition of the Chinese National Medical Products Association (NMPA) registration certification
• Amending the Scope of Authorization to describe a process FDA will use in removing respirators from Appendix A if FDA has reason to believe that the respirator is no longer eligible for authorization.
Under the new May 7 EUA, in order for a respirator to be added to Appendix A as authorized, one of the following eligibility criteria must be met:
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.
FDA will sample respirators from already imported lots of respirators under criterion three. If a manufacturer has not shipped respirators to the United States at the time this EUA is reissued, FDA will work with a manufacturer who is eligible for this criterion in order to sample respirators once they arrive at a US port of entry.
If respirators do not meet eligibility criteria, the respirator may still meet the eligibility criteria for authorization under the Face Masks (non-surgical) EUA. Additionally, during COVID-19, FDA generally does not intend to object to the importation and use of a respirator model outside of healthcare settings, as a general face mask, as described in FDA’s guidance entitled Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.
This information has been obtained directly from the FDA in one of their updates.