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Proposed Changes in Federal Oversight of Laboratory Developed Tests

November 4, 2023

The New England Journal of Medicine (Singhal, U., et al.) 11.04.2023, published a perspective article, “Modernizing Federal Oversight of Laboratory-Developed Tests — Toward Safety, Validity, and Utility.” In this article authors describe the current Federal oversight processes of Laboratory-developed tests (LDTs) and how it has evolved over time. They describe the potential harms that unregulated LDTs may have on patients as well as the potential obstacles that laboratories may face with innovation if regulations are too restrictive.

The scope and availability of LDTs were once limited, but innovation and advancements in technology combined with increased understanding of diseases has led to an increased use of LDTs in health care. Authors stress the importance of the need to balance regulatory protections and the burdens imposed on testing laboratories, in order to safeguard patients and preserve opportunity for scientific innovation.

Congress failed to pass “The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022,” which would have established a “risk-based regulatory framework” overseen by the FDA for LDTs, which are considered “in-vitro diagnostic products.” The FDA subsequently announced a proposed rule (09.2023), that would classify LDTs as “medical devices” under the Federal Food, Drug, and Cosmetic Act. The statute’s definition of “in vitro diagnostic products” is inclusive of tests produced by individual laboratories. As “medical devices,” LDTs would be subject to FDA’s review for safety and effectiveness and requirements for labeling and reporting.

Authors state that Federal regulation has not evolved with increased reliance on LDTs and that legislation required to make progress in this arena must implement a “unified regulatory framework focused on safety, validity, and utility.”

For More Information

Read the full The New England Journal of Medicine Perspective Article