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Senators Circulate Plan For Standalone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules

Senators are drafting legislation to create a standalone FDA Center to oversee diagnostics, including IVDs and LDTs, under a framework distinct from current medical device regulations.

Lawmakers in the Senate Health, Education, Labor, and Pensions Committee are circulating draft legislation to create a standalone center at FDA to regulate diagnostics as a distinct regulatory category from medical devices. The draft would establish a new framework for regulating ‘in vitro clinical tests’ (IVCTs), including in vitro diagnostic kits and lab-developed tests, if it becomes law, stakeholders say.

The concepts behind the legislation are contained in a March white paper, “A Proposed Regulatory Framework for In Vitro Clinical Tests,” developed by the Diagnostic Test Working Group,...

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