Federal Court Vacates FDA Rule on Laboratory Developed Testing Services, Siding with ACLA
Washington, D.C.— The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, today announced a victory in its legal challenge to the U.S. Food and Drug Administration’s (FDA) Final Rule that would have regulated virtually all laboratory developed testing services as medical devices. The U.S. District Court for the Eastern District of Texas has vacated the Final Rule in its entirety, holding that FDA’s attempt to regulate professional laboratory testing services as medical devices exceeds the authority granted to FDA in the Food, Drug, and Cosmetic Act (FDCA).
In an opinion that accepts many of ACLA’s primary arguments, the court found that “the text, structure, and history of the FDCA and [the Clinical Laboratory Improvement Amendments (CLIA)] make clear that FDA lacks the authority to regulate laboratory-developed test services.” The court emphasized that “devices” under the FDCA “are articles of commerce, not the kinds of services performed by doctors and laboratories,” and that Congress specifically addressed the regulation of clinical laboratories and their services through CLIA, an independent statutory framework.
“The court’s ruling ensures that clinical laboratories can continue to focus on their primary mission – offering innovative and reliable diagnostics that save and improve the lives of millions of patients every day,” said ACLA President Susan Van Meter. “This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country.”
Rejecting FDA’s request for further briefing, the court vacated the rule in its entirety, reinforcing that courts must “nullify and revoke” agency actions found to be illegal.
As a result of the decision, the Rule and its associated compliance deadlines are no longer in effect.
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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.
