FDA Puts Off Closing Lab-Test "Loophole," Leaving Decision To Congress And Trump
11/21/2016 7:17:21 AM
After arguing for months that certain medical tests led to patients being mistakenly told they had illnesses and undergoing pointless treatment, the Obama administration Friday dropped its plans to regulate them.
The Food and Drug Administration said a decision on whether and how to regulate the tests would be left to Congress and the new president.
The diagnostics, known as laboratory developed tests, are designed, manufactured, and used within a single laboratory, often in a hospital. They range from simple tests that measure levels of sodium to ones that analyze DNA and help diagnose genetic diseases.
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