Coalition Of Manufacturers, Labs Floats Alternative LDT Approach

April 20, 2015 at 3:13 PM
A coalition of diagnostic manufacturers and clinical laboratories is floating an alternative approach to oversight of laboratory developed tests (LDTs) that lays out distinct roles for FDA, CMS and the states, while stressing that the same regulatory system cannot meet the needs of both traditional medical devices and LDTs. This comes as FDA and CMS form an interagency task force to clarify the agencies' respective responsibilities, and the House Energy and Commerce Committee broaches the issue as part of its...

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