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(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/ Comments are closed.
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Southern Tier Health Care System, Inc.
150 North Union Street, Olean, NY 14760 |
