(May 7, 2020), the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria – the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer – and accordingly removed from Appendix A the respirators that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing.
Daniel J. Clayton, BS, EMT-P
Chief, Operations Section
Bureau of Emergency Medical Services
New York State Department of Health
875 Central Avenue
Albany, NY 12206
(518) 402-0996 | email@example.com |