FDA brings lab tests under federal oversight in bid to improve accuracy and safety

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration has finalized a rule to regulate medical tests that have long escaped oversight. The rule was announced Monday. It is designed to improve the accuracy and reliability of tests developed at large laboratories, including hospitals and universities. The FDA has warned for years that inaccurate test results can lead to unnecessary treatment and delays in getting proper care. Under the new requirements, labs will have about four years to win FDA approval for new tests. The FDA estimates there are about 80,000 medical tests already on the market. Those will not be required to get FDA approval.