SCOPE Summit for Clinical Ops Executives
Talk Biomarkers & Precision Medicine Trials track
FDA Regulation of LDTs: The Impact on Clinical Trials for Precision Medicine
Tue, Feb 4, 2025 · 5:05–5:25 PM EST Rosen Shingle Creek
About this session
In May 2024, the FDA issued a final rule amending the definition of in vitro diagnostic products (IVDs) to include laboratory developed tests (LDTs). This change subjects LDTs to the agency’s medical device regulations, including for investigational uses and clinical trials. Many tests for biomarkers and precision medicine are LDTs. This session will explain the new requirements for laboratories and the impact on clinical trials for precision medicine.
