Summary
FDA’s 2024 final rule amending the definition of in vitro diagnostic products to include tests manufactured by laboratories was vacated by a federal district court on March 31, 2025. FDA issued a September 19, 2025 final rule implementing the vacatur and reverting the regulation to the pre-2024 text. The original LDT rule should therefore be treated as historical rather than an active regulatory requirement.
Healthcare Implications
This is a major status change for AI-enabled diagnostic and laboratory-developed tests. The 2024 rule no longer creates active FDA oversight obligations for laboratory-developed tests, including AI-enabled or algorithmic diagnostic tests developed and used within laboratories. HAPI should not present the 2024 LDT final rule as an active source of current compliance duties.