The Association for Diagnostics & Laboratory Medicine (formerly AACC) opposes FDA ruling on laboratory developed tests; urges FDA to involve all stakeholders in modernization of laboratory developed test regulation in order to improve patient care
Association for Diagnostic and Laboratory Medicine (ADLM (formerly AACC))We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) strongly disagree with the Food and Drug Administration’s (FDA’s) decision to issue a final rule placing laboratory developed tests under duplicative FDA authority, in addition to these tests’ current regulation under the Centers for Medicare & Medicaid Services (CMS).
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