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 likely an effort to seek approval prior to the start of the Congressional Review Act lookback period that would be triggered in the event of a shift in the administration and Congress. That said, as we have noted previously, if the proposed LDT rule is finalized substantially as drafted, it is likely to be swiftly met with litigation challenging FDA’s authority to regulate LDTs.
We are continuing to monitor these LDT developments and will provide updates as they occur.
