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Title
Guidance Regarding the Deployment of the Emergency Use Approval (EUA) Bird Flu Test (H7N9) to State Public Health Laboratories (PHLs) by the Centers for Disease Control and Prevention (CDC)
Memo #
13-39-CLIA
Posting Date
2013-06-14
Fiscal Year
2013
Summary
• Guidance for Regional Office (RO) Surveyors—During routine biennial re-certification surveys of State PHLs, ROs must confirm that the H7N9 test was verified by each laboratory per the CDC protocol and the corresponding Clinical Laboratory Improvement Amendments (CLIA) policies and procedures are in place to ensure readiness and compliance in the event of an outbreak. • CDC Directions to State PHLs – Upon receipt of the bird flu test system and corresponding instructions and information, State PHLs will verify the centrally developed test specifications in their laboratory per the CDCs guidance. • Food and Drug Administration (FDA) Link for H7N9: http://www.fda.gov/medicaldevices/safety/emergencysituations/ucm161496.htm?source=govdelivery
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