Home use prothrombin time tests get CLIA waived status under FDA Modernization Act.
This article was originally published in The Gray Sheet
Executive Summary
PRESCRIPTION HOME USE TESTS GET CLIA "WAIVED" STATUS UNDER FDA REFORM BILL, which includes a provision stating that "laboratory examinations and procedures that have been approved" by FDA "for home use" qualify for Clinical Laboratory Improvement Amendments waived status. Although the provisions covers all home use tests, the primary effect of the measure will be ensuring that the Centers for Disease Control and Prevention includes prescription home use tests in the waived category.