On April 16, 2015, FDA and the Centers for Medicare & Medicaid Services ("CMS") announced an interagency task force intended to address stakeholder confusion regarding their respective roles in the regulation of laboratory developed tests ("LDTs"), or diagnostic products made and used in a single lab. The task force will bring together leaders and specialists from each agency to address a range of issues, including quality requirements for LDTs. Last year, FDA issued two draft guidance documents describing the agency's proposed framework for overseeing LDTs, which suggests FDA is gradually moving toward regulating this sector.
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