Emergency Use Authorization for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China

(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.
 
https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter?utm_campaign=2020-05-07%20Concerns%20with%20Filtering%20Facepiece%20Respirators%20from%20China%20-%20Letter%20to%20HCP&utm_medium=email&utm_source=Eloqua
 
 
 
 
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  | daniel.clayton@health.ny.gov |
https://www.health.ny.gov/professionals/ems/
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