The Association for Diagnostics & Laboratory Medicine (formerly AACC) recommends to Congress that the regulation and modernization of clinical tests be managed under the auspices of the Clinical Laboratory Improvement Advisory Committee, CMS, and Congress
Specifically, ADLM supports modernizing the Clinical Laboratory Improvement Amendments (CLIA), through which the Centers for Medicare & Medicaid Services (CMS) regulates laboratory developed tests.
- Specifically, ADLM supports modernizing the Clinical Laboratory Improvement Amendments (CLIA), through which the Centers for Medicare & Medicaid Services (CMS) regulates laboratory developed tests.
- Additional FDA oversight would be duplicative, costly — and could force many clinical labs to stop performing these essential tests.
- "As an alternative, ADLM suggests updating CLIA's standards through the Clinical Laboratory Improvement Advisory Committee (CLIAC).
- "Once changes are made through the regulatory process, ADLM proposes that Congress evaluate and update the underlying statute that governs CLIA.