LabCorp receives FDA warning letter
Device Regulation Alert: Safety, Compliance and Reimbursement News, October 13, 2008
Laboratory Corporation of America (LabCorp) is illegally marketing a blood test to detect ovarian cancer, according to an FDA warning letter.
According to the FDA, LabCorp did not submit an application for pre-market approval and did not receive an investigational device exemption for OvaSure, making the device adulterated. In addition, LabCorp failed to inform the FDA it was introducing the device into interstate commerce, making the device misbranded as well.
The FDA reported that Yale University researchers, not LabCorp, designed, developed, and validated OvaSure. Yale University researchers also allegedly developed instructions for use and performance characteristics.
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