Manatt Health May 6, 2024
The Big Picture
On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the same enforcement approach as other in vitro diagnostic (IVD) products. FDA had previously issued the proposed rule in September of last year.1 Despite this definitive step toward asserting jurisdiction over these tests, the path forward for the final rule is certain to be rocky, with litigation likely to ensue and possible action by Congress to move long-pending legislation to establish a separate regulatory regime for IVDs.
The rule’s effective date is July 5, 2024, but the FDA has set forward a “phaseout policy,” as...
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