The U.S. Food and Drug Administration (FDA) published a final rule amending its regulations to include in vitro diagnostic products (IVDs) as devices, even those manufactured in a laboratory, and issuing policy to phase out general enforcement discretion for laboratory-developed tests (LDTs), which are IVDs manufactured and used within a single clinical laboratory. LDTs are most often used in hospitals. The FDA finalized this rule over the objection of the American Hospital Association.

The phaseout of the FDA’s general enforcement discretion will occur in five stages over four years, with the first stage beginning in May 2025 and with each stage requiring LDTs to meet additional compliance requirements, such as quality system (QS) requirements. By Stage 5, the FDA will expect premarket review for certain LDTs. Based on comments the FDA received on the proposed rule, the agency intends to exercise enforcement discretion for QS requirements and premarket review for (1) LDTs that were first marketed prior to the issuance of the final rule and (2) LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within that healthcare system because the communication between laboratorians and physicians helps inform the appropriate use of LDTs.

To address IVDs outside the scope of general enforcement discretion and the phaseout, the FDA also announced that it drafted guidance documents identifying (i) its enforcement discretion policy for IVDs used to respond to emergent situations and (ii) factors the FDA intends to consider for developing an enforcement discretion policy for IVDs during a declared public health emergency. Comments on these draft guidance documents are due by July 5, 2024.

The final rule can be accessed here.

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