Fate of LDT Final Rule Sealed as Appeal Deadline Passes

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The Food and Drug Administration (FDA) decided not to appeal a issued on March 31 vacating the agency’s attempting to regulate laboratory developed tests (LDTs) pursuant to its authority to regulate medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). In the consolidated cases American Clinical Laboratory Association (ACLA) v. FDA and Association for Molecular Pathology v. FDA, the U.S. District Court for the Eastern District of Texas determined that clinical laboratory testing services are not “devices” under the FDCA and a laboratory performing such testing services is not a “device manufacturer.” Accordingly, the court held that FDA’s rulemaking exceeded the agency’s statutory authority under the FDCA.

FDA’s failure to challenge the ruling before the 60-day appeal window closed signaled that the agency has, at least for now, abandoned its efforts to broadly regulate LDTs. FDA’s decision not to defend the final rule is consistent with the previous Trump Administration’s stance regarding the FDA’s authority to regulate such tests, as well as the current Administration’s overall focus on deregulation.

Although the court invalidated the final rule, the Administration’s next steps are unclear because of some ambiguity regarding the applicability of the ruling to certain types of business models and aspects of laboratory testing. FDA could potentially interpret the ruling narrowly and attempt to assert oversight on some practices based on its current statutory authority. CMS could instead revise its regulations to provide more oversight over LDTs using its authority under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Alternatively, the Administration could advocate for Congress to pass legislation to provide a suitable regulatory framework for in vitro diagnostic tests.

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