• Access Compliance

FDA reissued the Emergency Use Authorization (EUA)



"...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."


Revised Appendix A: https://www.fda.gov/media/136663/download

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

Shared from VPPPA Region 2


#FDA #EUA #NIOSH #RespiratoryProtection #WorkplaceSafety #WorkplaceHealth

Latham Office

776A Watervliet-Shaker Road
Latham, NY 12110
518-782-2200

Utica Office

421 Broad Street Suite 12
Utica, NY 13501
800-732-8004

North Brunswick Office

622 Georges Road, Suite 202
North Brunswick, NJ 08902
732-296-1000

© 2019 by Access Compliance, LLC. Proudly created with Wix.com