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NEW YORK (GenomeWeb) – The US Food and Drug Administration today announced a proposal to establish procedures and criteria for the de novo classification of medical devices, including in vitro diagnostics. 

FDA Commissioner Scott Gottlieb said in a statement that the agency's goal is to make the pathway "significantly more efficient and transparent by clarifying the requirements for submission and our processes for review."

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The Washington Post reports that a US Senate committee voted this week to approve the nomination of Stephen Hahn to lead the Food and Drug Administration.

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