November 1, 2023: MGMA requests pause on LDT rulemaking

November 1, 2023 
 

Dear Chair Sanders, Ranking Member Cassidy, Chair McMorris Rodgers, and Ranking Member Pallone:

On behalf of the undersigned organizations that represent a diverse and broad community of patient advocates, laboratory professionals, public health laboratories, and clinical laboratories from throughout the United States, we write to express our significant concerns with recently announced plans by the U.S. Food and Drug Administration (FDA) to impose existing medical device regulations on laboratory developed testing procedures (LDTs). LDTs are testing services that hospitals, academic, public health, and clinical laboratories develop and use in patient care. These services are not commercially manufactured and marketed, but rather are designed, developed, validated, performed, and interpreted by board-certified professionals in a single laboratory. LDTs are often created in response to unmet clinical needs and are instrumental for early and precise diagnosis or monitoring and guidance of patient treatment including hereditary disease testing, oncology, infectious disease, and more. As such, FDA regulating them as medical devices would be inappropriate and disruptive to patient care.

We stand united in support of modernizing the oversight framework for high complexity clinical LDTs but primarily through reform of the long-standing Clinical Laboratory Improvement Amendments (CLIA). We believe that the modernization of CLIA requirements could better achieve a sustainable system that fosters innovation and promotes emerging medical knowledge to enable healthcare professionals the ability to offer precise, accurate, and the most up-to-date tests to patients. It is also the most streamlined and cost-effective approach, for both the government and laboratories, and the least disruptive and burdensome approach to ensuring clinical and analytical validity, transparency, and addressing other concerns expressed by interested stakeholders. Modernizing CLIA oversight will support laboratory advances in clinical care as validated discovery and innovation continue to develop rapidly.
 

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