Could the FDA Take an Indirect Approach to Regulate LDTs?

Scott Danzis’ commentary was included in a MedTech Dive article exploring the implications of a U.S. district court decision which vacated a Food and Drug Administration (FDA) rule that would have expanded the regulator’s authority over laboratory developed tests (LDTs).

“It’s certainly not hard to surmise that part of the story here was that this current FDA, the current administration, just wanted to go in a different direction than the FDA final rule,” Scott said. “I also do believe that the decision that was issued was clear and strong and would have been difficult to overcome in an appeal.”

Scott added that although the FDA lacks jurisdiction over test services, as the district court ruled, the agency could still use its authority over the instruments and other physical objects used by laboratories that are regulated as devices. The FDA’s warning letter to a German diagnostics company offers an example of how the agency could pursue a less direct path to regulate laboratory developed tests now that the court has quashed its attempt to broaden oversight. This letter, he said, is “conceivably one example of that.”