On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding regulations under development by federal agencies. In its preamble, the Department of Health and Human Services (“HHS”) notes that the regulatory actions forecasted for the Agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration, HHS, and the U.S. Food and Drug Administration (“FDA”).

As we analyzed in detail in recent articles (see here, here and here), the proposed rule for laboratory developed tests (“LDTs”) was released in October 2023.  Citing factors including “extensive background of public comment on this topic” and “the public health benefits of proceeding expeditiously,” FDA declined to extend the 60-day comment period, which closed on December 4, 2023.  FDA received over 6,000 comments from individual citizens, laboratories, academic medical centers, and other industry stakeholders.  As part of the Agenda, FDA has updated the target date for final action on the LDT proposed rule to April 2024.

FDA is under no obligation to publish the LDT rule according to the schedules reflected in the Unified Agenda.  If the rule and related LDT policy are finalized as proposed by April 2024, high-risk LDTs may be called-in for premarket review as early as October 1, 2027. Subsequently, low-to-moderate risk LDTs may be called-in for premarket review as early as April 1, 2028.

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