As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s regulatory authority. Such a rule would be FDA’s first comprehensive attempt to impose its authority over LDTs since its 2014 draft guidance, which FDA ultimately chose not to finalize, and comes after several failed congressional legislative attempts to do the same.

The June notice, publicized via the Biden administration’s Unified Agenda of Regulatory and Deregulatory Actions, suggested the proposed rule would be released during August 2023. According to the White House Office of Information and Regulatory Affairs (“OIRA”) website, the FDA’s proposed rule was sent to OIRA for review on July 26, 2023.  This is the final step before FDA can publish the proposed rule in the Federal Register and initiate the notice-and-comment period, and usually takes around 90 days to complete. Therefore, the timeline for release of the proposed rule could shift back slightly to the Fall of 2023, though it is not unheard of for OIRA to approve a proposed rule on a shorter timeframe.

As a refresher, the exact contents and structure of the proposed rule remain a mystery. However, there is potential for significant shifts in the landscape of laboratory testing, and the proposed rule will likely result in litigation around FDA’s authority to regulate LDTs (and possibly other products). 

We will continue to update you on FDA’s LDT activities as they occur.

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