On May 6, 2024, the US FDA published its final rule on laboratory developed tests (LDTs) in the Federal Register (1). Most of the document is considered a preamble discussing background/justification, a phase-out policy of enforcement discretion, and the FDA’s responses to public comments on the proposed rule. The final rule itself is essentially a 10-word addition to the definition of in vitro diagnostic products (IVDs) found in the US Code of Federal Regulations.