FDA Proposed Rule to Regulate LDTs as Medical Devices Would Slow Development of Critical Lab Tests and Should be Withdrawn, ACLA Urges

FDA Regulation of LDTs is Misguided; Requires Congressional Authorization

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today submitted comments urging the U.S. Food and Drug Administration (FDA) to withdraw its proposed rule to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. 

LDTs are an indispensable pillar of the nation’s health care system, providing patients and physicians with diagnostic information to inform clinical care, power precision medicine, contribute to the discovery of novel therapeutics, and lead the fight against emerging pathogens. Laboratories and the LDTs they develop have made – and continue to make – extraordinary contributions to the public health. FDA’s proposed rule, if finalized, would jeopardize the ongoing ability of laboratories to develop and offer innovative LDTs essential to delivering the latest scientific advances in diagnostics to patient care.  

“ACLA has grave concerns with FDA’s proposed rule, both as a matter of public policy and law, and urges FDA to withdraw it,” said ACLA President Susan Van Meter. “FDA fails to provide a sound justification for its unilateral action, which would impose ill-suited and inflexible medical device authorities on LDTs. The net result of this action would be to reduce patient access to essential testing, including for rare diseases, and hamper innovation in the next generation of diagnostics. Device authorities are rigid and would not allow LDTs to keep pace with scientific advances. Further, the proposed rule exceeds FDA’s legal authority, as LDTs are not devices and cannot be regulated as such.”

In its comments, ACLA provided a detailed assessment of FDA’s cost-benefit analysis included in proposed rule. In short, FDA significantly underestimates the costs associated with implementing the rule and vastly overestimates the claimed benefits.  

The FDA’s proposed rule fails to recognize the essential role that LDTs play in health care delivery and the already significant federal and state regulation and assessment of LDTs. In fact, laboratories and the LDTs they offer are subject to robust regulation under federal and state statutes, supplemented by rigorous accreditation standards and review by payers.

For several years, ACLA has worked collaboratively with FDA, Congress, and key stakeholders on legislation that could have established an appropriate regulatory system for all diagnostics, complementary to the already robust oversight of LDTs. The goal has been to develop a regulatory approach that would account for the unique attributes of laboratory diagnostics while balancing diagnostic innovation, maintaining access to important tests, and regulatory oversight. 

ACLA steadfastly maintains that legislation is the right – and only – approach for further oversight of LDTs. ACLA believes the proposed rule represents regulatory overreach and should be withdrawn.

Read the full comment letter here.


The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

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