FDA In Vitro Diagnostic Chief: Industry Exploits Loophole On Waived Tests

FDA's in vitro diagnostic chief in an interview with Inside Health Policy said industry is exploiting a loophole in the statutory framework for laboratory developed tests under which companies can obtain waived status for any test approved by the agency for over-the-counter use. With a waived designation, proficiency testing, a step some sources say is critical to understanding the real-world risk profile of tests, is not required and laboratories are exempt from reviews under the Clinical Laboratory Improvement Amendments (CLIA)...