Expect a legal battle before the US Food and Drug Administration’s proposed rule on lab-developed tests can be put into effect, a former FDA chief counsel told Medtech Insight.
Former FDA Chief Counsel Expects Lawsuits Over Agency's LDT Proposal
Clinical labs seem poised to file lawsuits arguing that the US Food and Drug Administration does not have the right to regulate lab-developed tests. And those lawsuits have some chance of success, former FDA chief counsel Dan Troy told Medtech Insight.
