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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 [email protected].

Click here for the white paper.