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House Diagnostics Reg Reform Draft Proposes Pathways For Relaxed Scrutiny

A House Subcommittee plans to take up draft legislation at a hearing next month that brings together test kits and lab-developed tests into a new regulatory category. The proposal offers many ways for tests to avoid a “high-risk” classification. “The Gray Sheet” compares the provisions to recent proposals vetted in the Senate.

The House Energy and Commerce Health Subcommittee will consider a legislative discussion draft

to establish new regulated medical product category of in vitro clinical tests to counter FDA’s proposed laboratory developed test (LDT)...

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