Senators Circulate Plan For Stand-alone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules
This article was originally published in The Pink Sheet Daily
Senators are drafting legislation to create a stand-alone FDA Center to oversee diagnostics, including IVDs and LDTs, under a framework distinct from current medical device regulations.
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A bill under development by Sen. Orrin Hatch, R-Utah, would carve out a new center at FDA for regulating all advanced diagnostics, according to stakeholders familiar with recent versions of the draft legislation.