Bass, Berry & Sims attorneys Danielle Sloane and Heather Pearson authored an article for the American Bar Association (ABA) sharing insight on the Food and Drug Administration’s (FDA) final rule issued in May 2024 to regulate laboratory developed tests (LDTs) as medical devices, which will present new obligations for an industry historically shielded from FDA enforcement. The change will affect how in vitro diagnostic products (IVDs) and other LDTs are regulated by the FDA.
Some stakeholders are challenging this final rule in federal court, teeing up an argument on the scope of the FDA’s authority to regulate LDTs as medical devices in a post-Chevron world. The industry is holding its breath hoping the court rules before laboratories have to invest in infrastructure to comply with the rule’s Stage One compliance deadline of May 6, 2025. The rule details a four-year, stage-based approach to ending the decades-long enforcement discretion policy over LDTs.
“It is prudent for laboratories to watch closely as these lawsuits unfold and evaluate how much time they need to ensure that they are well positioned to comply with the FDA’s medical device reporting (MDR) requirements, correction and removal, and Quality System (QS) complaint file requirements by May 6, 2025,” Danielle and Heather said.
The full article, “How to Comply with Stage One of the Laboratory Developed Tests Final Rule,” was published by the ABA Business Law Today on October 11 and is available online.