Personalized or precision medicine relies on accurate diagnostic tests. The U.S. Food and Drug Administration’s (FDA) recent final rule now explicitly designates Laboratory Developed Tests (LDTs) as devices under the Federal Food, Drug, and Cosmetic Act. This move aims to enhance the safety and effectiveness of LDTs used in a single clinical laboratory.

Previously, the FDA exercised enforcement discretion over most LDTs. However, due to concerns over their complexity and increased use in health care decisions, the FDA is now increasing oversight. The transition away from enforcement discretion will take place over four years, with some exceptions for certain in vitro diagnostic products.

This regulatory change is crucial to ensure that health care decisions are based on trustworthy test results. For more details on the final rule and its implications, visit the FDA’s official resources.

“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, M.D. “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.”

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