Navigating the new norm: The FDA's final rule on laboratory developed tests (LDTs) and its impact on clinical laboratory operations
Authors
Rob E. Carpenter
Publication date
September 16, 2024
Journal
Navigating the new norm: The FDA's final rule on laboratory developed tests (LDTs) and its impact on clinical laboratory operations
Volume
48
Pages
1-8
Publisher
Elsevier
Description
On April 29, 2024, the U.S. Food and Drug Administration (FDA) issued a transformative final rule impacting the regulatory landscape for laboratory-developed tests (LDTs). This new regulation categorizes in vitro diagnostics (IVDs) used as LDTs under the same stringent oversight applied to other medical devices, thereby phasing out the agency's long-standing policy of enforcement discretion. This paper offers a concise historical overview and examines the FDA's revised regulatory framework scheduled for the next four years, analyzing its impact on laboratory operations in terms of safety, efficacy, and innovation. It analyzes how the new rule's increased compliance demands and economic implications impact laboratory operations, including economic stability, innovation, and patient safety. Also highlighted is how certain laboratories gain strategic advantages that could enhance their market stability and attract …