US FDA publishes final rule for laboratory developed tests

The US Food and Drug Administration (FDA) on Monday published the final rule to ensure safety and effectiveness of laboratory developed tests (LDTs), which are designed, manufactured and used within a clinical laboratory.

These tests are used to collect, prepare and examine biological specimens such as blood, saliva or tissue to diagnose, monitor or determine treatment for diseases and conditions, according to the FDA.

The rule requires LDTs to be classified as devices under the Federal Food, Drug, and Cosmetic Act, FDA said, adding that it intends to provide greater oversight of these tests.

“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,” FDA Commissioner Robert Califf said in a statement.

The agency, which has not generally enforced any applicable requirements with respect to most LDTs, said it has become increasingly concerned that some of these tests may not provide accurate results or perform as well as FDA-authorized tests and others complying with FDA requirements.

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