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House Committee Seeks Feedback on LDT Regulation

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The House Energy and Commerce Committee is soliciting feedback from “all interested stakeholders” on just about every central issue related to FDA’s proposal to regulate LDTs.

The Committee posted a white paper on December 9 that lists eleven broad questions covering everything from the definition of a diagnostic device, to risk definitions, to what incentives should be provided to encourage innovation.

The Committee has requested input by January 5, 2015, and all comments should be sent to cures@mail.house.gov.

Click here for the white paper.