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29 de may. de 2024 · ACLA maintains that legislation is the right – and only – approach for FDA to regulate professional testing services offered by laboratories.
Hace 5 días · In ACLA’s complaint, the association — which was joined by HealthTrackRX, and endorsed by testing providers such as Labcorp and Quest Diagnostics — wrote that LDTs are not individual products, but services, meaning that they are outside of FDA jurisdiction.
31 de may. de 2024 · The litigation was initiated by the American Clinical Laboratory Association (“ACLA”) and a private laboratory, HealthTrackRx. The complaint alleges that the final rule violates the Administrative Procedure Act—the federal law governing challenges to agency action—in two ways:
31 de may. de 2024 · According to ACLA, FDA has overstepped its authority by attempting to regulate professional laboratory testing services as medical devices, which are federally regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments.
29 de may. de 2024 · NEW YORK – The American Clinical Laboratory Association (ACLA) and its member company HealthTrackRx said Wednesday that they have filed a lawsuit against the US Food and Drug Administration challenging the agency's May 6 final rule on laboratory-developed tests (LDTs).
30 de may. de 2024 · The American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration on Wednesday, arguing the agency does not have the authority to regulate laboratory developed tests as medical devices.
30 de may. de 2024 · The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, filed a lawsuit on May 29 against the U.S. Food and Drug Administration (FDA) over the agency’s recent final rule to regulate laboratory-developed tests (LDTs) as medical devices.
