US FDA announces amendment to Food Drug and Cosmetic Act to include IVDs in scope
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US FDA announces amendment to Food Drug and Cosmetic Act to include IVDs in scope

THE WHAT? The US FDA has clarified that in-vitro diagnosis products (IVDs) are devices under the Food, Drug and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.

THE DETAILS The change has been prompted by the wider use of laboratory developed tests (LDTs) for a larger and more diverse population. Furthermore, there is a growing body of evidence that demonstrates that some LDTs are inaccurate, unsafe, ineffective or poor quality, raising public health concerns.

THE WHY? FDA Commissioner Robert M. Califf, explains, “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. 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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