FDA Ensures Safety and Effectiveness of Laboratory Developed Tests
Under the modification to the Food, Drug, & Cosmetics Act, individuals and health care providers can hopefully have more confidence in in vitro diagnostic devices.
The FDA recently took action to strengthen the safety and effectiveness of laboratory developed tests (LDTs), following their increased use in health care decisions. Defined as in vitro diagnostic devices (IVDs), LTDs were intended for clinical use and were “manufactured and used within a single clinical laboratory that meets certain regulatory requirements,” according to study authors. The FDA announced a final rule that modified the the agency's regulation to make IVD devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Over the course of 4 years, the FDA will work to phase out its general enforcement discretion approach for LDTs.1
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IVDs are often used in health care during the collection, preparation, and examination of specimens taken from the human body, such as blood, saliva, and tissue. The study authors noted that these IVDs can offer information about an individual’s health by measuring and detecting substances or analytes that can determine treatment for diseases and conditions.1
In March of 2024, the FDA began efforts to dismiss its previous enforcement discretion policy for LDTs and aimed to adjust them as medical devices. However, the study authors noted that the FDA’s ability to regulate LDTs has been an ongoing issue for over a decade.1,2
The study authors noted that the FDA previously did not require LDTs to undergo FDA approval as medical devices via premarket approval (PMA). However, the FDA's typical enforcement policy applies to direct-to-consumer (DTC) tests, which are not all FDA-approved and are available without a prescription.2 Because the most modern LDTs carry a greater risk than LDTs used when the FDA’s enforcement discretion approach was originally implemented, the agency is reconsidering its non-enforced applicable requirements.1
In response to an upsurge of LDT complexity in 2014, the FDA released a draft guidance that outlined regulatory gaps in the devices, which included safety monitoring for adverse events and market removal of unsafe devices. Additionally, the guidance identified a lack of manufacturing oversight, which could result in device defects.2
The study authors noted that IVDs presented as LDTs raised concerns, as they did not provide accurate tests results and do not perform as effectively as FDA-approved tests.1
“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 results of these tests without assurance that they work,” said FDA Commissioner Robert M. Califf, MD, in a press release. “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.”1
Further oversight is needed of the safety and effectiveness of LDTs to ensure that patients do not undergo unnecessary treatment or delay treatment based on inaccurate test results from LDTs, according to study authors. Under the FD&C, individuals and health care providers will hopefully have more confidence in IVDs, as the act requires premarket review, quality system requirements, adverse event reporting, establishment registration, and device listing, labeling requirements, and investigational use requirements.1
“Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a press release. “Through targeted enforcement discretion policies for certain categories of tests manufactured by a laboratory, we expect patients and health care professionals will continue to have access to the tests they need while having greater confidence that the tests they rely on are accurate.”1
