US FDA finalizes rule to phase out enforcement discretion for laboratory-developed tests (LDTs), treating them like other in-vitro diagnostic (IVD) products over a four-year period.

The US FDA has finalized a rule to phase out its long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), treating them similarly to other in-vitro diagnostic (IVD) products. A "phaseout policy" will end enforcement discretion over a four-year period, starting with medical device reporting requirements, and culminating with the enforcement of premarket review requirements for high-risk IVDs. The final rule also introduces new enforcement discretion policies for specific categories of tests, such as those approved by the New York State Clinical Laboratory Evaluation Program.