AdvaMed Statement on the Release of FDA Rule on Laboratory-Developed Tests

WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, released the following statements from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s final rule for Laboratory Developed Tests (LDTs):

“We appreciate FDA’s commitment to ensuring the safety and effectiveness of in vitro diagnostic tests, regardless of their source, which is what today’s rule would accomplish,” Whitaker said. “We hope this rule is just the first step toward comprehensive reform of the framework for diagnostic test regulation overall, which the VALID Act would accomplish through Congress. This reform is critical to supporting the continued innovation of safe, effective, and high-quality diagnostic tests.”

“This rule represents significant progress in ensuring that diagnostic tests, regardless of where they were developed, meet FDA’s rigorous standards for safety and effectiveness,” Rothstein said. “We also encourage Congress to pass the bipartisan VALID Act, which would establish a modernized, diagnostics-specific regulatory framework for all diagnostics tests. We remain committed to advocating for this important legislation and we look forward to continuing our collaboration with Congress and all stakeholders in these efforts.”

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GLS’ President and CEO, Maria Thacker Goethe in December's issue of Georgia Trend

December 4, 2025

Georgia Life Sciences’ CEO, Maria Thacker Goethe shares her perspective on the value of Georgia’s research universities in this month’s issue of Georgia Trend. “Georgia research institutions have felt a very significant impact from the federal rollbacks, specifically in NIH and NSF funding. Thacker Goethe’s message about the impact of research cuts is simple: Disruption shatters the foundational trust researchers have in grant continuity….” To read the full article, click here .