CLIA IVD COMPLEXITY CATEGORIZATION PROGRAM SHIFT TO CDC ON HOLD
This article was originally published in The Gray Sheet
Executive SummaryCLIA IVD COMPLEXITY CATEGORIZATION PROGRAM SHIFT TO CDC ON HOLD as a result of concerns raised by the Office of Management and Budget, according to FDA and Centers for Disease Control and Prevention staffers. Until the issues are resolved, FDA will continue to assign complexity categories for new in vitro diagnostics under the Clinical Laboratory Improvement Amendments of 1988 and refer its decisions to CDC for concurrence.
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