New OIVD Director Says FDA May Need To Go Back To 'Square One' on IVDMIA Guidance
August 12, 2009
New OIVD Director Says FDA May Need To Go Back To 'Square One' on IVDMIA Guidance
OIVD Director Alberto Gutierrez acknowledged that the dual regulatory pathway — through CMS under the Clinical Laboratory Improvement Amendments and through the FDA — creates "an uneven playing field" for diagnostics developers.
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