Upcoming Congressional Hearing on Lab Test Regulation

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The U.S. House of Representatives Committee on Energy and Commerce is holding a hearing entitled “Examining the Regulation of Diagnostic Tests and Laboratory Operations” on November 17 at 2pm ET (note that the date was re-scheduled from an earlier date).

The hearing will consider proposed legislation which could augment/supplant FDA’s proposal for regulating LDTs with a broader regulatory approach covering all diagnostic tests.

I haven’t read the proposed legislation yet in full, but congressional insiders claim that the bill closely follows the Diagnostic Test Working Group Proposal that was drafted by industry leaders earlier this year.

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