FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests

Key Takeaways

• The final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
• The final rule mandates that all IVDs, including those developed in laboratories, comply with the same Federal Food, Drug, and Cosmetic Act requirements as other medical devices.
• The FDA will phase out its policy of LDT enforcement discretion over the next four years in five stages, transitioning to active oversight of LDTs.

The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that the FDA has described as intended for clinical use and designed, manufactured, and used within a single clinical laboratory that meets certain regulatory requirements. The final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer of the IVD is a laboratory. This substantial update comes after decades during which the FDA exercised enforcement discretion, largely refraining from regulating LDTs.

Under the new rule, the FDA will phase out its policy of enforcement discretion over the next four years in five stages, transitioning to active oversight of LDTs. The FDA's action responds to the increasing complexity and widespread use of LDTs in critical healthcare decisions, such as cancer screening, heart disease diagnosis, and Alzheimer's detection. According to FDA Commissioner Robert M. Califf, the rule aims to ensure that LDTs provide reliable results that healthcare providers and patients can trust.

The final rule mandates that all IVDs, including those developed in laboratories, comply with the same FD&C Act requirements as other medical devices. This includes adherence to premarket review processes, quality system regulations, adverse event reporting, establishment registration, device listing, and labeling requirements.

Despite the shift toward stricter regulation, the FDA will maintain targeted enforcement discretion for certain categories of LDTs. This includes LDTs that were marketed before the rule's implementation and those developed within integrated healthcare systems to address unmet needs when no FDA-approved alternatives are available.

We recommend that our healthcare and life sciences clients impacted by the change prepare for the expanded regulatory requirements, implement effective compliance strategies, and stay abreast of legal developments as the industry adjusts to the FDA's new oversight approach. If you need assistance understanding the impact of this rule on your operations or developing compliance strategies, please contact your BakerHostetler attorney, Winston Kirton or Laura Macherelli with any questions.