New FDA Device Rule No Cure for Unregulated Lab Tests

Healthcare policy attorney Michael Werner was quoted in a Law360 article discussing the new rule giving U.S. Food and Drug Administration (FDA) authority over lab-developed tests (LDTs). The new regulation classifies LDTs as medical devices under the federal Food, Drug and Cosmetic Act instead of in vitro diagnostic testing (IVDs). With this change, the FDA hopes to increase the safety and accountability of tests after there were concerns LDTs, categorized as IVDs, could give flawed results and impact patient treatment. Currently, the agency doesn't know how many LDTs are on the market but will begin to phase out the previous process by requiring test makers to register and provide information about their tests. However, Mr. Werner said he expects a "swath of tests" to stay unregulated.

"While the agency is creating a system that in many ways is more clear and, in many ways, will bring more LDTs under its regulatory authority, there are still tests that are not," he said.

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