DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate

The FDA has published a final rule to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act. The publication of the rule has far-reaching implications for the quality and availability of diagnostic tests in the United States, as well as impacts on pharmaceutical product research. This session will discuss the final rule in a panel format, focusing on the impact to various stakeholders, as well as current compliance efforts and next steps for ensuring compliance. The session will also address the impact of the recent election, legislative and executive actions, and litigation, on the FDA’s regulation of laboratory developed tests.

Learning Objectives

List requirements of the LDT Final Rule and phased approach to regulation; Summarize implications of the FDA LDT Final Rule for patients, developers, health care systems, providers and regulatory decision making; Discuss approaches to implementing requirements of the final rule.

Chair

Courtney Granville, PhD, MPH