FDA Has Published Its Final Regulations Regarding Laboratory-Developed Tests

(CTN News) – In a final rule published on Monday by the US Food and Drug Administration (FDA), the agency seeks to ensure the safety and effectiveness of laboratory-developed tests (LDTs) designed, manufactured and used within a clinical laboratory setting.

Accordant to the Food and Drug Administration, a biological specimen such as blood, saliva, or tissue may be collected, prepared, and examined to determine individual health status, monitor the progress of diseases and conditions, or diagnose, monitor, and determine the treatment of the disease or condition in question, according to the FDA.

Activating the new rule will require that LDTs be classified as medical devices under the Federal Food, Drug, and Cosmetic Act, the FDA said in a statement. It added that it intends to guarantee that these tests are effectively supervised in order to ensure safety.

A statement from FDA Commissioner Robert Califf was released today in which he said that the final rule had played an important role in providing critical oversight over the use of these tests in order to ensure that patients and health care providers are able to rely on test results in order to make necessary decisions.

Although the FDA has not generally enforced any applicable requirements with respect to most LDTs, it has become increasingly concerned with some of these tests that may not provide accurate results or that may not perform as well as FDA-authorized tests and others that are in compliance with regulations.

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