FDA WARNING_LETTER - Laboratory Corporation of America

The FDA issued a Warning Letter to Laboratory Corporation of America (LabCorp) on September 29, 2008, regarding its OvaSure™ device. The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) reviewed information from LabCorp's website, including a press release and technical bulletin, and a meeting with FDA on September 5, 2008.

The FDA determined that OvaSure™ was designed, developed, and validated by Yale University investigators, not LabCorp, and that materials for the test were manufactured by a third party based on Yale's specifications. The FDA concluded that OvaSure™ is a device under section 201(h) of the FDCA, intended for disease diagnosis, and is not within the scope of traditional laboratory developed tests for which the agency exercises enforcement discretion.

LabCorp is in violation of the law because it lacks marketing clearance or approval for OvaSure™ from the FDA. The device is adulterated under section 501(f)(1)(B) of the Act for not having an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under section 502(o) for failure to notify the agency of intent to introduce the device into commercial distribution, as required by section 510(k).

LabCorp must take prompt action to correct these violations. Failure to do so may result