The U.S. Food and Drug Administration (FDA) published a final rule overhauling its approach to the regulation of laboratory developed tests (LDTs) on May 6, 2024. The final rule, which is largely similar to the proposed rule that was issued seven months prior in October of 2023, makes it explicit that LDTs will be considered medical devices regulated as in vitro diagnostics (IVDs) under the Federal Food, Drug, and Cosmetic Act (FDCA). Over a four-year period, the FDA will phase out its general enforcement discretion approach to LDTs, under which LDTs may be marketed without FDA premarket review. However, the FDA outlined targeted enforcement discretion policies for certain categories of tests manufactured by laboratories.
This rule does not align with the modernized regulatory framework we have been advocating for through the Verifying Accurate Leading-Edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act,…
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