Davar Discusses FDA LDT Rule With RAPS and 360Dx

Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was quoted in the Regulatory Affairs Professionals Society (RAPS) article, “FDA publishes LDT rule ‘CliffsNotes’ in guidance for small companies,” and in the 360Dx article, “Changing Legal Environment Adds Uncertainty to ACLA Lawsuit Against FDA Over LDT Rule.” The two articles discuss the U.S. Food and Drug Administration’s (FDA) final rule related to laboratory-developed tests (LDTs), strengthening the administration’s oversight over these tests.

The FDA recently published guidance for small entities that produce LDTs, which Davar says raises the fundamental question of whether the FDA possesses the authority to regulate LDTs as outlined. “FDA will say that this is part of its public health mission to help labs come into compliance and this is a very clear statement of compliance,” he told RAPS. “This is also one step further for FDA to firm up its ground if it chooses to in the coming year to inspect or take enforcement [actions].” He added that the FDA’s guidance, which was unsurprising, illustrates how serious the FDA is about enforcing its LDT rule.

Davar also discussed the American Clinical Laboratory Association’s (ACLA) recent lawsuit against the FDA’s LDT rule, telling 360Dx that “in the final rule, FDA doesn't — I think in ACLA's view and the view of many — do enough to satisfy from the legal standard how it is that it can regulate the people and the processes and the service part of this.” He added that the large number of “carve-outs” in the rule could potentially weaken the FDA’s legal stance, a concern echoed in the ACLA’s complaint. Davar noted that he does not represent ACLA or HealthTrackRx in its lawsuit.

Read the full RAPS article, “FDA publishes LDT rule ‘CliffsNotes’ in guidance for small companies.”

Read the full 360Dx article, “Changing Legal Environment Adds Uncertainty to ACLA Lawsuit Against FDA Over LDT Rule" (subscription required).