CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tests that are used by healthcare professionals […]
FDA Notifies Congress that It Will Regulate LDTs
Federal agency proposes risk-based oversight for 2,000 clinical laboratories offering 11,000 LDTs
- By Joseph Burns
- > From the Volume XXI No. 11 - August 11, 2014 Issue
- Tags: aco, arup lab, arup laboratories, association for molecular pathology, cap, clia, clia 1988, clia lab, clia laboratories, clinical lab, clinical laboratories, companion diagnostic, Companion diagnostics, fda regulation of ldts, genetic test, genetic tests, genomics, impac, lab executive, laboratories, ldt, medical lab, medical laboratories, molecular lab, molecular pathology, pathologists, pathology test, pharmacogenomics, the laboratory
