Resultado de búsqueda
Hace 5 días · 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. The trade group wants the FDA’s final rule vacated, according to a lawsuit filed in the U.S. District Court for the Eastern District ...
Hace 1 día · ACLA lawsuit. 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. The trade group said that interpreting and delivering diagnostic ...
Hace 6 días · ACLA maintains that legislation is the right – and only – approach for FDA to regulate professional testing services offered by laboratories. The industry remains committed to working with Congress, FDA, and other stakeholders to advance appropriate legislation that preserves the critical role of laboratory diagnostics and ensures that patients continue to have access to lifesaving tests.
Hace 4 días · May 31, 2024. The American Clinical Laboratory Association (ACLA), a national trade association that represents clinical laboratories, filed a lawsuit against the Food and Drug Administration on Monday challenging the agency’s final rule on laboratory-developed tests. As described in an AABB Regulatory Update, the final rule takes a sweeping ...
Hace 5 días · The association challenges the agency’s May 6 final rule that gives the FDA explicit authority to regulate certain medical tests that come from a single laboratory, known as lab-developed tests (LDTs). The lawsuit is the first to seek to block the FDA rule. The ACLA and ...
13 de may. de 2024 · The ACLA, which represents the nation’s largest commercial reference laboratories such as LabCorp, Quest Diagnostics, and Mayo Clinic, has long maintained that medical device authorities are ill-suited for LDTs and that diagnostic regulation should come through Congress.
Hace 4 días · Instead, ACLA said that new congressional legislation should be the only method to increase the FDA’s oversight of LDTs, and that testing services are already regulated under the Clinical ...
