College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule

Since the US Food and Drug Administration published its April final rule assuming regulatory authority over lab-developed tests, or LDTs, the agency has attracted its share of detractors opposed to the move.

The American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) have filed lawsuits seeking to block the rule, arguing LDTs are not medical devices, but rather laboratory...