Tag: Clia

“Today, we at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) provided testimony to Congress regarding the impact of the Food and Drug Administration’s (FDA’s) proposed rule to impose FDA oversight on laboratory developed tests in addition to Centers for Medicare & Medicaid Services (CMS) oversight. While we share FDA’s goal of ensuring that laboratory developed tests are safe and effective, we have serious concerns about the agency’s proposal. If finalized, this rule would create a burdensome dual regulatory structure that would limit patient access to many life-saving tests.