FDA: Final Rule Declares Laboratory Developed Tests to be Medical Devices
On 29 April, the Food and Drug Administration (FDA) issued a final rule that will phase out its general enforcement discretion approach for laboratory developed tests (LDTs) over a four-year period.
This decision was prompted by concerns about the potential inaccuracy or poor performance of certain tests compared to FDA-approved in vitro diagnostic (IVD) products. The final rule includes changes to FDA regulations that explicitly classify IVD products, including LDTs, as devices subject to the Federal Food, Drug, and Cosmetic Act.
After a four-year transition period, the FDA will require all IVD manufacturers to comply with the same applicable device standards. The phaseout includes targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories. The rule is scheduled to take effect 60 days after its publication in the Federal Register on 6 May.
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