FDA’s fast-moving LDT rule obtains White House clearance, paving the way for publication


A final rule requiring Laboratory Developed Tests (LDTs) to be regulated as medical devices has obtained clearance from the White House’s Office of Information and Regulatory Affairs today, allowing the FDA to publish the regulation as early as this week. Simultaneously, OIRA also cleared two additional guidance documents that seek to define how diagnostics are used in public health emergencies, which are likely intended to answer key questions raised by the LDT final rule.

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