The U.S. Food and Drug Administration released a final rule on April 29 regarding the regulation of laboratory-developed tests (LDTs).
The final rule amends existing regulations regarding LDTs — defined by the FDA as in vitro diagnostic products (IVDs) intended for clinical use and designed, manufactured, and used within a single clinical laboratory — designating all IVDs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer of the IVD is a laboratory.
The final rule establishes a four-year phase-out period of the general FDA enforcement discretion approach for LDTs. Additionally, targeted enforcement discretion policies have been issued by the FDA for certain categories of IVDs manufactured by laboratories.
“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust,” FDA Commissioner Robert M. Califf, M.D., said in a statement.
According to the FDA, the final rule addresses growing concerns regarding the safety and reliability of modern LDTs. The FDA intends to maintain greater oversight of LDTs through its application of the device requirements found in the FD&C Act, including premarket review, quality system requirements, adverse event reporting, establishment registration and device listing, labeling requirements and investigational use requirements.
The FDA will continue to exercise enforcement discretion regarding premarket review and most quality system requirements for certain categories of IVDs, including: those IVDs offered as LDTs before the issuance of the final rule on April 29 and LDTs manufactured and performed by a laboratory integrated within a health care system to meet a need of patients receiving care within that health care system when an FDA-authorized test is unavailable.
The final rule is scheduled for publication on May 6, 2024, and will be accessible in the Federal Register.
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