Bass, Berry & Sims attorneys Danielle Sloane and Heather Pearson contributed content for an article examining hot legal topics in the life sciences industry to watch in 2025. Danielle and Heather outlined the Final Rule from the Food and Drug Administration (FDA) requiring greater oversight for laboratory developed tests (LDTs). As the authors point out, “This highly contentious final rule is a seismic shift in how LDTs are regulated from decades-long enforcement discretion to an extensive regulatory framework under FDA’s medical device authorities.”
The Final Rule makes the FDA’s position clear that LDTs are medical devices and requires that many LDT manufacturers comply with some or all of the FDA’s medical device regulations according to a multi-year regulatory plan. The authors describe this plan and outline the FDA’s exclusion of “several categories of LDTs from some more burdensome later stage requirements, such as premarket review.”
Since the Final Rule was released in early May 2024, there have already been challenges to the FDA’s “statutory authority to regulate LDTs as medical devices” that “could undermine the agency’s ability to enforce compliance with the final rule.” In the article, the authors examine the challenges that have been brought by the American Clinical Laboratory Association (ACLA), HealthTrackRx and the Association for Molecular Pathology (AMP).
The full article, “Hot Topics in Life Sciences to Watch in 2025,” was published in the November/December 2024 edition of the American Health Law Association’s (AHLA) Health Law Connections and is available online (subscription required).