Industry Concerns Amid Regulatory Uncertainty
As the May 6, 2025, implementation date for Phase One of the FDA’s LDT Final Rule approaches, clinical laboratories face ongoing uncertainty. The rule mandates that laboratories comply with specific regulatory requirements, including medical device reporting, correction and removal reporting, and complaint file quality system requirements. However, the pending legal challenges have created a “regulatory haze,” making it difficult for laboratories to determine whether to commence compliance efforts. Industry experts advise laboratories to stay informed and prepare for potential compliance obligations, despite the uncertain regulatory environment.
More details at: A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule | Epstein Becker Green.
Trump Administration’s Defense of FDA’s LDT Rule
In a move that surprised some legal experts, the Trump Administration’s Department of Justice robustly defended the FDA’s authority to regulate LDTs during a federal court hearing on February 19, 2025. This defense counters a lawsuit filed by major laboratory groups, including the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), which argue that the FDA’s final rule overreaches its statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA). The plaintiffs contend that the regulation of LDTs should fall under the purview of the Centers for Medicare and Medicaid Services (CMS) as mandated by the Clinical Laboratory Improvement Amendments (CLIA), not the FDA’s medical device regulations.
Read the full story here: Trump administration’s defense of LDT rule catches legal expert by surprise | RAPS