A potential resolution to a lingering debate on how the government should oversee laboratory-developed diagnostic tests would focus the FDA’s attention on the more cutting-edge and riskier screening tools.
At issue is a disagreement between device companies and clinical laboratory groups on what constitutes appropriate federal oversight of laboratory-developed test (LDTs), which are developed in a single laboratory, compared to the same type of diagnostics made by device companies.
Scott Gottlieb, commissioner of the Food and Drug Administration, unveiled Sept. 13 a proposal for how his agency could regulate in vitro diagnostic tests, or tests on bodily samples, that...
For more stories, analysis and expertiseOR Request Trial
(Adds comments from industry representatives in the tenth, 11th, and 15th paragraphs.)