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.
May 13, 2024
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