E&C Floats Draft LDT Bill Creating FDA In Vitro Center, Defining Risk Categories, Mandating Review Timeline

The House Energy & Commerce Committee is floating laboratory developed test (LDT) language that would create an in vitro center within FDA that reports directly to the agency commissioner as do other agency centers. The discussion draft , obtained by Inside Health Policy , would classify LDTs into three distinct risk classes based upon how well the test is characterized and whether an adverse result would have a significant impact on patient health. It would also set a timeline for...