FDA brings lab tests under federal oversight
The Food and Drug Administration has finalized a rule to regulate medical tests that have long escaped oversight.
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The Food and Drug Administration has finalized a rule to regulate medical tests that have long escaped oversight.
Makers of medical tests will have about four years to show that their new offerings deliver accurate results, under a government rule.
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The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable.
WASHINGTON (AP) — Makers of medical tests that have long escaped government oversight will have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry. The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests […]