WASHINGTON – The Food and Drug Administration says it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.
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The agency says its proposal is designed to make sure the tests — which are used to diagnose various diseases and conditions — are safe, accurate and reliable.
While the FDA has long reviewed test kits made by manufacturers, it has never exercised authority over tests developed and used in medical laboratories. Generally these tests were simple and not widely used.
But the FDA says laboratory tests have become increasingly sophisticated, often testing for genetic information, and now compete with manufactured tests that have undergone rigorous FDA review.
Under its proposal, FDA would review higher-risk laboratory tests before they could be marketed.