CHA News

FDA Finalizes Rule on Laboratory-Developed Tests

What’s happening: The Food and Drug Administration (FDA) finalized a regulation of laboratory-developed tests (LDTs), effective July 5. 

What else to know: The final rule amends FDA regulations to make explicit that in vitro diagnostic (IVD) products, which include LDTs, are devices under the Federal Food, Drug, and Cosmetic Act.  

The final rule phases out the FDA’s general enforcement discretion approach for most LDTs over four years, citing concern that some of the tests may not provide accurate results or perform as well as FDA-approved IVD products.  

After four years, the agency would require all IVD makers to meet the same applicable device requirements, except where FDA has decided to apply enforcement discretion for certain device rules, such as those for premarket requirements and quality systems.  

The FDA intends to exercise limited enforcement discretion for certain categories of IVDs, including LDTs developed and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system and currently marketed LDTs first marketed before the final rule’s issuance date. 

The agency released draft guidance on the rule’s enforcement discretion policy during an infectious disease outbreak or public health emergency.