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UrduToday, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), together with the American Association of Bioanalysts, American Society for Clinical Pathology, American Society for Microbiology, and the Infectious Disease Society of America, has filed an amicus brief in the case of American Clinical Laboratory Association (ACLA), et al. v. U.S. Food and Drug Administration (FDA), et al.
Tag: healthcare regulations
Association for Diagnostics & Laboratory Medicine (formerly AACC) Statement on Proposed FDA Rule on Laboratory Developed Tests
We at the Association for Diagnostics & Laboratory Medicine were disappointed to see the U.S. Food & Drug Administration’s (FDA’s) attempt to circumvent Congress with its new proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under the Centers for Medicare and Medicaid Services.
AACC Statement on Non-Invasive Prenatal Screening Tests
We share the FDA’s goal of alerting the public to the potential misuse of non-invasive prenatal screening (NIPS) tests. This is why we’ve been advocating for the modernization of how laboratory-developed tests (LDTs) are regulated by the Centers for Medicare and Medicaid Services (CMS).
The Importance of Laboratory Developed Tests in Diagnosing COVID-19
Laboratory developed tests play a vital role in getting patients accurate diagnoses and effective care, and at no time has their importance been clearer than during the current pandemic. In this briefing, AACC’s leading experts in laboratory medicine will discuss why laboratory developed tests are crucial to fighting the coronavirus, as well as the regulatory barriers that nearly prevented labs from developing and introducing these tests for the virus.
AACC Welcomes HHS Decision to Clarify Federal Regulation of Laboratory Developed Tests
AACC welcomes a decision from the Department of Health and Human Services that the Food and Drug Administration does not have authority to regulate laboratory developed tests (LDTs) without formal notice-and-comment rulemaking.