The landscape of laboratory-developed tests (LDTs) is facing a significant regulatory shift as the US Food and Drug Administration (FDA) proposes to regulate them as medical devices. The new proposed rule published in October 2023 states the FDA’s intention to regulate LDTs, including those that are manufactured by a laboratory, as in vitro diagnostics (IVDs). The agency’s goal is to ensure the safety and effectiveness of these tests to prevent potential harm to patients from false results or claims. Those against this potential ruling must submit their comments by 4 December 2023. Groups such as ARUP Laboratories have spoken against this rule, urging the FDA to reconsider, citing concerns about the potential impact on innovation and patient access to essential tests.
