As the Food and Drug Administration (FDA) advances its attempt to regulate laboratory-developed tests (LDTs), the U.S.-based Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) and many others in the laboratory community question whether the agency has the authority to exert such oversight. The ADLM also warns that the attempt could drastically limit patient access to important laboratory tests and even cripple some laboratories.
The FDA released a proposed rule on October 3, 2023, that would allow the agency to regulate LDTs as medical devices, similar to in vitro diagnostic (IVD) test kits manufactured by IVD companies.
Specifically, the FDA wants to change its regulations so that IVDs are considered medical devices under the Food, Drug, and Cosmetic Act, “even if the manufacturer of those products is a laboratory.” Although the proposed new regulatory text is only 10 words long, the FDA dedicates more than two dozen pages to the rationale for why it believes regulating LDTs is necessary.
FDA Goes All In to Regulate Laboratory Developed Tests | myADLM.org
