April 29, 2024: The FDA announced a final rule to ensure the safety and effectiveness of laboratory developed tests (LDTs). This rule clarifies that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) even when manufactured by laboratories. The FDA is phasing out its general enforcement discretion for LDTs over four years, transitioning to greater oversight and targeted enforcement for certain IVD categories.
Background on LDTs: LDTs are in vitro diagnostics used within a single, CLIA-certified laboratory. These tests analyze human specimens (e.g., blood, saliva) to provide health information, such as diagnosing or monitoring diseases. Historically, the FDA used discretion in enforcing regulations on LDTs, but advancements in technology and broader use of these tests necessitate stricter oversight.
Increased Oversight: Due to growing concerns about LDT safety and effectiveness, the FDA has engaged with stakeholders since 2010, leading to the 2023 proposed rule and the 2024 finalization. The FDA aims to provide assurances that LDTs are safe and effective, preventing false results and potential patient harm.
Phaseout Policy: The transition includes five stages, starting from May 6, 2025, to May 6, 2028. Laboratories will progressively need to comply with medical device reporting, quality system requirements, and premarket review requirements for high- and moderate-risk IVDs. Specific categories, such as direct-to-consumer tests and public health surveillance tests, will have tailored enforcement discretion policies.
Resources and Webinars: The FDA provides various resources on device regulation and plans to host webinars on the phaseout policy. More information and updates will be available on the FDA’s Laboratory Developed Tests: Frequently Asked Questions page.
For detailed information on the phaseout policy stages and enforcement discretion categories, laboratories and stakeholders can refer to the FDA’s official announcements and regulatory documents.