FDA Seeks Oversight of Lab-Developed Tests; Cites Patient Risks

December 16, 2015 | Strategic Insights for Health System


Claiming that laboratory-developed testing conducted by hospitals and others is unregulated, the U.S. Food and Drug Administration (FDA) wants to boost its oversight of the tests but is encountering resistance, says a December 10, 2015, article in the Wall Street Journal. The agency says that the 1976 statute that gave it the authority to regulate medical devices extends to laboratory tests. Indeed, FDA does have oversight of diagnostic machines and test kits sold in the United States, but when the 1976 law was passed, little attention was paid to the regulation of lab-developed tests because only a few institutions provided the testing. Today, lab-developed testing is a multibillion-dollar-a-year industry with an estimated 100,000 tests offered, including tests for heart disease, ovarian cancer, Lyme disease, whooping cough, and autism, the article says. In a recent report outlining the need for FDA oversight of lab-developed tests, the agency cited examples of inaccurate tests placing patients at otherwise avoidable risk.

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