LDTs are in vitro diagnostic tests designed, manufactured and used within a single laboratory, according to the FDA’s website. In recent draft guidance, the agency proposed regulating these tests in the same manner as medical devices.
The American Hospitals Association said in a statement it has repeatedly discouraged the FDA from regulating LDTs as medical devices, arguing the regulatory framework would decrease patient access to important tests and hinder both technological and clinical innovation. Instead, AHA suggested the FDA should update the Clinical Laboratory Improvement Amendments to better regulate LDTs.
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