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Legal Challenge to FDA LDT Rule Inevitable, Davar Says

June 6, 2024

Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was quoted in the MedTech Dive article, “Lab industry sues to stop FDA’s new LDT rule,” which discusses the American Clinical Laboratory Association’s (ACLA) recent lawsuit against the U.S. Food and Drug Administration’s (FDA) final rule related to laboratory developed tests (LDTs). The FDA’s rule strengthens the administration’s oversight over LDTs, which the ACLA argues is beyond its authority.

Davar told MedTech Dive that a legal challenge to the final rule was inevitable. “We will be watching the docket closely to see how [the] FDA responds and how the litigation unfolds,” Davar said. “In the interim, companies will be assessing whether or not to invest in building the systems and compliance programs needed to prepare for the first years of the phase-in proposal.”

Read the full article.