Advocacy - Lab Advocate
In November 2024, ADLM submitted a letter to President-elect Donald J. Trump’s transition team recommending the revocation of the FDA’s May 2024 final rule on laboratory-developed tests (LDTs). This rule expands FDA oversight of LDTs, introducing new regulatory requirements that pose challenges to laboratories and the delivery of diagnostic services.
Currently, LDTs are regulated under the Clinical Laboratory Improvement Amendments (CLIA) by the Centers for Medicare and Medicaid Services (CMS). The FDA’s rule reclassifies LDTs as medical devices, a change that introduces operational challenges and increased compliance costs. These requirements could constrain the availability of LDTs, particularly for critical diagnostic areas such as rare diseases, cancer, and emerging public health threats.
ADLM joined a coalition of leading clinical laboratory organizations, including the American Clinical Laboratory Association and the Infectious Diseases Society of America, to further emphasize the broad opposition to the FDA’s actions. The coalition highlighted that the FDA’s rule duplicates existing regulatory frameworks and lacks statutory authority. It also noted the rule’s rushed implementation process, which diverts resources from patient care and innovation.
The coalition urged the incoming administration to immediately suspend enforcement of the rule and initiate a formal withdrawal process. These steps would help maintain patient access to vital diagnostic services while ensuring laboratories can focus on their mission to deliver high-quality care.
ADLM remains committed to preserving the accessibility and innovation of laboratory-developed tests and will continue to work with stakeholders to advocate for a streamlined regulatory approach that supports both patient care and laboratory operations.