News | Medtech Insight

Former FDA Chief Counsel Expects Lawsuits Over Agency's LDT Proposal

October 5, 2023

Dan Troy comments that clinical labs will likely file lawsuits after the US Food and Drug Administration’s recent proposal to regulate lab-developed tests (LDTs), and that those lawsuits will have some chance of success. Regardless of the outcome, he expects a legal battle before the FDA’s proposed rule can be put into effect.

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Dan Troy

Managing Director

Washington, DC