On July 18, 2008, the Hematology and Pathology Devices Advisory Panel met to provide recommendations to the U.S. Food and Drug Administration (FDA) on issues relevant to granting CLIA waiver status to the automated hematology complete blood count (CBC) with differential cell count. The panel provided recommendations on whether this type of device would be appropriate for use in a CLIA waived setting along with specific recommendations regarding the FDA pre-analytical, analytical, and post-analytical questions.
The Open Public Hearing session gave the public an opportunity to provide input on this issue. Three speakers addressed the panel. The first recommended the panel not find the CBC with differential eligible for waiver because of the potential for harm from use in settings without conventional laboratory controls or regulation. The second two both spoke to the value of having a waived test to increase access to valuable laboratory information.
Contact: Louise E. Magruder, Executive Secretary; 240-276-1248; or firstname.lastname@example.org
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