The U.S. Food and Drug Administration (FDA) took action to help ensure the safety and effectiveness of laboratory-developed tests (LDTs) that are used in a growing number of healthcare decisions. There have been a growing number of concerns raised about these tests for many years.
 
LDTs are in vitro diagnostic products (IVDs) the FDA has described as “intended for clinical use and designed, manufactured, and used within a single clinical laboratory that meets certain regulatory requirements.”
 
Many LDTs are used for diverse populations with large laboratories accepting specimens across the U.S. LDTs rely on high-tech instrumentation and software, are performed in large volumes, and are used more frequently to help guide healthcare decisions.
 
The FDA announced a final rule amending its regulations making 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 (i.e., LDTs). 
 
The FDA also issued a policy to roll out its general enforcement discretion approach for LDTs over a four-year period. In addition, the agency issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
 
Growing evidence shows some IVDs offered as LDTs raise public health concerns. The FDA is aware of many examples of potentially unsafe, inaccurate, or ineffective IVDs offered as LDTs that may have caused patient harm.
 
FDA Commissioner Robert M. Califf, M.D. said: “LDTs are being used more widely than ever before—for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to rely on the results of these tests without assurance that they work. 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.”
 
The roll out of the FDA’s general enforcement discretion approach for LTDs aims to protect public health to ensure the effectiveness of these tests. After the roll out, the FDA will expect non-laboratory or laboratory IVDs to meet the same requirements. 
 
The FDA intends to exercise enforcement discretion concerning premarket review and most quality system requirements for certain categories of IVDs. Effected categories include but are not limited to: currently marked IVDs offered as LDTs that were marketed before the date of issuance of the final rule, and LDTs manufactured and performed by a lab integrated with a healthcare system to meet the needs of patients when an FDA-authorized test is not available.