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Making Moves – FDA’s LDT Proposed Rule Sent to OMB for Review
Categories: FDA, Litigation, Medical Devices
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As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of Information and Regulatory Affairs (“OIRA”) within the Office of Management and Budget (“OMB”). While review by OIRA is capped at 90 days by Executive Order 12866, there is no minimum period required, and therefore action can be taken any time between now and June.

During this election year, FDA’s efforts to push the rule forward fairly quickly is ...

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