Fortune April 29, 2024
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-19, 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...
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