FDA brings lab tests under federal oversight in bid to improve accuracy and safety
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.
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 developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, Covid, genetic conditions and many other illnesses are safe, accurate and reliable.
“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust,” said FDA commissioner Robert Califf, in a release.
Califf said inaccurate tests can lead to unnecessary treatment or delays in getting proper care.
But in a significant move, the FDA decided that the tens of thousands of tests currently on the market will not have to undergo federal review. The agency said it will essentially grandfather those tests into approval to address concerns that the new rule “could lead to the widespread loss of access to beneficial” tests.
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